Clinical Trials

The purpose of this study assess the current patient practice (standard of care) on Health Related Quality of Life (HRQOL), perceived stress level and disease activity in female patients with Inflammatory Bowel Disease (IBD).

The management of Inflammatory Bowel Disease (IBD) is complex and time consuming. While Current Procedural Terminology for MTM services are available they are under-utilized given the time constraints placed on practitioners trying to address multiple health care issues during a single visit. There are companies that specialize in patient pharmacy services to improve health care outcomes. Our aim is to utilize these services in a small number of IBD patients to assess effectiveness of such services within a tertiary care practice.

The specific objectives of this study are to define infliximab thresholds during induction therapy and during maintenance therapy (visit 6) that are associated with good prognosis/response, study the correlation of inflammation markers such as serum CRP and fecal calprotectin with infliximab and antibodies-to-infliximab, and evaluate  how soon after initiation of therapy there is development of antibodies-to-infliximab

A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease study is being conducted at the University of California San Francisco and 30 other sites around the United States who are part of the CCFA Clinical Alliance. The aim of this study is to determine the effect of medication use and disease activity on the outcome of pregnancy among women with IBD up to 18 years from birth.

In this study, we will examine the potential side effects experienced after receiving the new hepatitis B vaccine (Heplisav-B) in patients with ulcerative colitis or Crohn's disease. This new vaccine has been found to be more effective than the existing vaccine Engerix in people without ulcerative colitis or Crohn's disease. It is now the standard of practice vaccine that we use in the Mayo gastroenterology and liver practice. The most common side effects include pain, redness, swelling, fatigue, fever and headache. We would also like to determine if there was any worsening of the patient's underlying inflammatory bowel disease.

The purpose of this study is to identify blood cell-specific DNA methylation and micro RNA markers in tissue and stool samples in patients wiht inflammatory bowel disease.

The purpose of this study is to better understand disease development of Irritiable Bowel Disease (IBD) and related diseases as a step to improving disease outcomes.

The purpose is to put the information into a very large database, which can then be used to improve patient care and achieve the best health outcomes possible for children with IBD.

The aim of this study is to test the validity of the current question database in a large cohort of children with Inflammatory Bowel Disease (IBD) in several pediatric gastroenterology centers. 

This investigation constitutes an initial evaluation of the stoma occlusion device in humans with a mature permanent Brooke ileostomy. The overall objective of this study is to assess feasibility and initial operating characteristics of a novel stoma occlusion device. The study will recruit 20 patients for placement of the device into the mature Brooke ileostomy and subsequent 2 hour observation period. The device will remain in the ileostomy for up to 2 hours.

The purpose of this study is to evaluate whether serum infliximab concentrations measured at the time of loss of clinical response will identify pediatric patients with inflammatory bowel disease (IBD) who would benefit (regain clinical response) from dose escalation above the currently approved dose.

The purpose of this study is to test the immune response to the Human Papillomavirus Vaccine in girls who have inflammatory bowel disease. The vaccine may not respond well in these girls, either due to having IBD or due to the immunosuppressants used to control IBD.

The purpose of the study is to compare the addition of structured psychosocial care versus standard medical care alone for the treatment of adult patients who have inflammatory bowel disease

The primary aim of this study is to compare the degree and characteristics of disease-related knowledge of patients with IBD between Korea (3 tertiary referral hospitals) and USA (Mayo clinic, Rochester, Minnesota) via the use of a questionnaire and medical record review.

The purpose of this study is to determine the impact of systemic immunosuppression on sustained antibody COVID-19 concentrations in patients with inflammatory bowel disease (IBD) who received a COVID-19 vaccine.  This observational study will collect blood samples to measure sustained antibody concentrations to evaluate seroprevalence and study immunity  at 6 and 12 months after completion of vaccination.  The primary outcome of this study is to evaluate the immunogenicity of the Covid-19 vaccine in patients with IBD.

The purpose of this study is to measure small intestinal and colonic permeability in 20 patients with active Inflammatory Bowel Disease (IBD), 20 patients with IBD in remission, and to compare with already acquired data from 60 healthy controls.

A subsidiary aim is to acquire new data in 20 healthy controls in order to ensure that the measurements of intestinal and colonic permeability in this cohort are consistent with those previously acquired in 60 healthy controls whose diet was standardized by meals prepared by the diet kitchen.

The goal of this study is to create a cohort of patients with Inflammatory Bowel Disease (IBD) who have linked clinical data, self-reported outcome data, and biosamples that can be used for clinical and translational research that will lead to medicine strategies and new therapeutic targets that will improve the quality of life of patients with IBD.

Our overall objective with this study is firstly to provide a comprehensive assessment of intestinal permeability, mucosal barrier function using existing biomarkers and secondly to explore novel biomarkers for measuring intestinal permeability in patients with constipation predominant Irritable Bowel Syndrome (IBS-C).

This study is being done to evaluate the safety and effects of Food and Drug Administration (FDA) approved medication, Eluxadoline, on bowel function in study participants with IBS-D who do or do not have bile acid malabsorption (BAM). Eluxadoline has been approved by the FDA for people with IBS-D but it is not known whether it will work the same way in people with IBS-D who also have BAM.

Will Ranolazine improve bowel function and abdominal pain in human subjects with IBS-D?

The purpose of this study is to compare a limited magnetic resonance enterography (MREN) to routine MREN in order to determine non-inferiority, missed findings, patient tolerance and impact on patient management. 

The purpose of this study is to demonstrate the effectiveness of ozanimod compared to placebo on the maintenance of clinical remission and endoscopic response.

This study will primarily evaluate the safety and efficacy of GS-5745 in adults with active Crohn's disease. The study will consist of a Blinded Treatment Period of 8 weeks followed by an Open Label Extension. Participants who complete the Blinded Treatment Period will be eligible to enroll in the optional Open Label Extension for an additional 44 weeks.

The objectives of this study are to use a questionnaire to detect Spondyloarthritis (SpA) manifestations will be administered to consecutive patients seen in participating IBD centers with a confirmed diagnosis of IBD, and perform a retrospective chart review to extract clinical data collected as routine standard of care during IBD office visits, including patient demographics, IBD phenotype, disease severity and activity, medication exposures, history of prior rheumatologic diagnoses, and other parameters related to axial and peripheral SpA.

The purpose of this extension study is to evaluate the safety and effectiveness of ozanimod in subjects with moderately to severely active Crohn's Disease.

The purpose of this study is to evaluate the effectiveness and safety of MEDI2070 in subjects with moderate to severe crohn's disease who have failed or are intolerant to anti-tumor necrosis-factor-alpha therapy.

The purpose of this study is to evaluate the long-term effectiveness, safety, and tolerability of giving repeat doses of ABT-494 to treat patients who have Crohn's disease.

This longitudinal study is being done to understand mechanisms underlying development of irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms. This information will be used to determine whether temporal changes in gut microbial taxonomy and metabolism are associated with changes in symptom severity in IBS, and if targeted dietary interventions, including prebiotics, can reverse or moderate these changes.

This is a randomized, double blind, placebo controlled, parallel group, multiple dose study to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of subjects in remission (total Mayo Score < 2 points with no individual subscore > 1 point) at week 8. After completing all screening assessments and meeting all eligibility criteria, subjects will be randomized to receive placebo or AMG 181 at various doses per protocol. A maximum of approximately 50% of subjects with any prior anti-TNF agent use will be allowed in the study. At the end of the double blind period, ...

This Phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in patients with moderately to severely active ulcerative colitis (UC) who are naïve to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.

This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease. The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease. There will be assessment of mucosal disease activity at baseline and 6- and 12- month follow ups. Patient satisfaction questionnaires will be completed at baseline, 6- and 12- month follow ...

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

This study will evaluate the efficacy and safety of two adalimumab induction regimens in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration.

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

The objectives of this study are to perform measured testing of the stricture PRO tool, including validation and assessment of responsiveness, and to assess responsiveness of the magnetic resonance image-based stricture radiology index (SRI) items.

The purpose of this study is to evaluate the effectiveness of TAK-018 in reducing endoscopic recurrence of intestinal inflammation in postoperative participants with CD after a planned laparoscopic ileocecal resection with primary anastomosis.

This is an investigational study, also known as LATTICE-CD, of the experimental medication BMS-986165 in participants with moderate to severe Crohn's Disease, a chronic bowel disease that causes severe inflammation of the digestive tract.

The purpose of this study is to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

The purpose of this study is to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn's Disease.

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).

The purpose of this study is to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active crohn's disease

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF therapy is more effective than treatment with anti-TNF therapy alone in inducing and maintaining steroid-free remission for children with Crohn's Disease.

The primary purpose of this study is to create a prospective registry of patients with pouch-related conditions to allow for longitudinal assessment of outcomes at 3, 6 and 12 months after a enrollment with a specific diagnosis (acute pouchitis, CADP, CARP, or CD of the pouch).

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

The purpose of this study is to evaluate how well risankizumab works compared to ustekinumab to treat Crohn's disease.

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. 

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single dose of 20 million cells. 20 patients (age 12 to 17 years) with Crohns perianal fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure ...

The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous [IV]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously [SC]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed Crohn's Disease (CD) stratified at higher risk for complications.

The purpose of this study is to evaluate the effects, safety and how OPS-2071 (150, 300, or 600 mg twice a day [BID]) is as an add-on therapy in Crohn's disease who show symptoms of active inflammation despite being on ongoing treatment.

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD).

The primary purpose of this study is to evaluate the effectiveness and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.

The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as compared to a non- Cimzia® control population. The SECURE Registry's target enrollment is 4000 patients and it's objective is to monitor patients for approximately 10 years.

The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.

The purpose of this study is to analyze patient outcomes after ileal pouch anal anastomosis.

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28 days. This exploratory study will also serve as a signal seeking endeavor to demonstrate biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic, and histologic assessments.

The purpose of this study is to test the effectiveness and safety of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease.

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

The purpose of this study is to evaluate the efficacy of SHP647 as maintenance therapy in subjects with moderate-to-severe Crohn's disease.

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active Crohn's disease (CD).

The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old in other countries and determine if it is similar to that observed in adults with moderately to severely active Crohn's disease (CD). Also to assess the safety, immunogenicity and efficacy of ustekinumab in the treatment of moderately to severely active CD. The main part of the study continues to Week 16, at which point all subjects who are receiving benefit from ustekinumab maintenance therapy ...

The purpose of this study is to evaluate the effects of Remicade (infliximab) for the treatment of active Crohn's disease and  may be useful in preventing a relapse of Crohn's disease after surgical resection.

The purpose of this study is to evaluate the efficacy and safety of SHP647 in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

The purpose of this study is to evaluate if specific blood, stool and MRI tests can tell the difference between bowel wall inflammation without scarring and bowel wall inflammation with scarring that can cause bowel blockages requiring surgery.

This is a randomized, double-blind, placebo-controlled, parallel group, multiple dose study to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of subjects in remission (CDAI score < 150) at week 8 (primary endpoint). After completing all screening assessments and meeting all eligibility criteria, subjects will be randomized to receive placebo or AMG 181 at various doses per protocol. A maximum of approximately 80% of subjects with any prior anti-TNF agent use will be allowed in the study. At the end of the double blind period, subjects will enter an open-label period during which all ...

The primary objective of this study is to evaluatge whether ustekinumab induces a similar proportion of pediatric participants with moderate-to-severe, active Crohn's disease into clinical remission at Week 1-8 compared with the proportion observed in adult participants with moderate-to-severe, active Crohn's disease randomized to ustekinumab in the CNTO1275CRD3001 and CNTO1275CRD3002 studies.

To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.

The global primary objectives of this study are, in pediatric participants with moderately to severely active ulcerative colitis (UC):

• To evaluate the efficacy of ustekinumab dosing in inducing clinical remission;
• To evaluate the safety profile of ustekinumab;
• To evaluate ustekinumab exposure (pharmacokinetics [PK]).

The United States (US)-specific primary objectives of this study are, in pediatric participants with moderately to severely active UC:

• To evaluate the efficacy of ustekinumab dosing in maintaining clinical remission among participants who were in clinical response in induction;
• To evaluate the safety profile of ustekinumab;
• To evaluate ustekinumab exposure (pharmacokinetics [PK]).

The overall objective of this proposal is to evaluate the potential therapeutic benefit of a whole-food, plant-based (WFPB) diet in patients with Crohn’s disease (CD). Our hypothesis is that patients adhering to WFPB diet will achieve higher rates of clinical remission and reduction in intestinal inflammation, as compared to controls who will implement FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet.  In order to further understand the pathogenesis by which diet may influence CD, we will also plan to study how WFPB may induce changes in the gut microbiota and intestinal permeability. We will test these hypotheses through ...

The purpose of this study is to evaluate the effectiveness, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 36 weeks of treatment.

The purpose of this study is to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

The purpose of this study is to assess the effectiveness of a new multi-parameter ultrasound technology for evaluation of Crohn’s disease.

To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.

The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition ...

The purpose of this study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of remission in subjects with moderately to severely active Crohn's disease (CD).

The purpose of this study is to assess the safety and effectiveness of PF-00547659 (experimental drug) for patients who have Crohn's disease that is clinically active despite conventional treatment.

The purpose of this study is to assess the effectiveness of a new ultrasound technology for evaluating Crohn's disease.

The study consists of 3 sub-studies, as follows: 

Sub-study 1 (Randomized, double-blind, placebo controlled study)

• The purpose is to evaluate the effectiveness and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately-to-severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991.

Sub-study 2 (Randomized, exploratory maintenance study)

• The purpose is to evaluate the effectiveness and safety of two different dosing regimens for risankizumab (therapeutic drug monitoring vs clinical assessment for dose escalation) as maintenance therapy in subjects with moderately to severely active CD who responded to induction treatment in Study M16-006 or Study M15-991.

Sub-study 3 (Open-label, long-term ...

This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderate to severely active CD in participants who are refractory or intolerant to corticosteroids (CS), immunosuppressants (IS), or anti-tumor necrosis factors (anti-TNFs) or have inadequate response to anti-tumor necrosis factor (TNF-IR). Participants who enroll on the basis of refractory or intolerance to CS and/or IS may have been previously exposed to anti-TNFs or be naïve to anti-TNFs. The study period will consist of Screening Phase (up to 35 days) plus (+) 14-week Induction Phase ...

The purpose of this study is to evaluate the effectiveness, safety, pharmacokinetics (PK), and immune response of high and low doses in 3 different weight groups of vedolizumab intravenous (IV) for maintenance of remission in children aged 2 to 17 years, inclusive, who weigh ≥ 10 kg with moderately to severely active Crohn’s disease (CD).

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).

The purpose of this study is to evaluate the effectiveness and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

The primary purpose of this study is to evaluate the effectiveness and safety of treatment with filgotinib on the induction and maintenance of remission in subjects with moderately to severely active ulcerative colitis (UC). Subjects who are biologic-naïve and biologic-experienced will be enrolled in Cohorts A and B, respectively. Treatment assignments will be randomized within each Cohort.

Participants who complete the study, or do not meet protocol response or remission criteria at Week 10, will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899).

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899).

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients diagnosed with moderate to severe ulcerative colitis.

The purpose of this study is to understand and document the concepts relevant and important to the measurement of signs, symptoms, and related experiences of patients living with stricturing CD for development of a new PRO instrument.

This study will evaluate the long term efficacy, safety, and tolerability of repeated administration of adalimumab in subjects with Crohn's disease.

The purpose of this study is to define and genotype the immunomodulatory properties of mesenchymal stem cells (MSCs) from Crohn’s disease subjects as compared to healthy/control subjects (diverticulitis, ulcerative colitis or subjects with perianal disease including hemorrhoids, cryptoglandular fistula, anal fissure, anal skin tags) or colon and rectal subjects.

The purpose of this study is to evaluate safety and efficacy of ozanimod in subjects with moderately to severely active Crohn's Disease.

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. After 12 weeks in the study until the end of the study, patients who do not have an improvement in their ...

The purpose of this extension study is to monitor the safety and effectiveness of etrolizumab treatment in patients with moderate to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896).

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).

This study will evaluate the effectiveness, safety, and tolerability of GS-5745. It will consist of 2 parts: Induction Study (Cohort 1) and Maintenance Study (Cohort 2). Participants in each part will receive either active GS-5745 or a placebo.

The purpose of this study is to evaluate the safety, tolerability and microbiome dynamics of SER-287 in subjects with mild-to-moderate ulcerative colitis.

The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with rizankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.

This study is conducted to determine whether the rates of birth defects, miscarriages, premature births and other outcomes in women with inflammatory bowel disease (IBD) taking azathioprine/6MP or biologic therapy (Remicade®, Humira®, Cimzia™, Tysabri®, or Stelara®) are different from those among IBD - affected women not taking these medications.

This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and ...

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).

The purpose of this study is to assess the integrated effect of normalization of intestinal dysbiosis through a structured semi-vegetarian dietary intervention in active UC patients who will also be under the standard of care medical therapy (vedolizumab).

This study seeks to identify predictive fecal, blood, and tissue biomarkers, in which biomarkers can be used to identify responders that will be reflective of disease severity or predict response to Janus Kinase Inhibitor Therapy. The benefits to the sub-study are to develop a population PK/PD model to characterize the relationships between local and systemic drug exposure and clinical, endoscopic, histologic, or biologic response to therapy.  Study also seeks to collect safety data from these subjects on Janus Kinase Inhibitor Therapy.

The purpose of this research is to determine if different diets have different effects on the micribiome and inflammation of your colon.

The purpose of this study is to evaluate the effectiveness, safety, pharmacokinetics (PK), and immune response of high and low doses in 3 different weight groups of vedolizumab intravenous (IV) for maintenance of remission in children aged 2 to 17 years, inclusive, who weigh ≥ 10 kg, with moderately to severely active ulcerative colitis (UC).

The purpose of this study is to assess the effectiveness and safety of SER-287 in adults with active mild-to-moderate ulcerative colitis.

This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission in participants with moderately to severely active ulcerative colitis (UC) who are refractory to or intolerant of TNF inhibitors.

The purpose of this study is to evaluate the efficacy of SHP647 as maintenance therapy in participants with moderate to severe ulcerative colitis (UC) who achieved clinical response in induction studies.

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

The purpose of this study is to evaluate the effectiveness and safety of ustekinumab used as the initial treatment, given by IV, and as maintenance treatment, injected subcutaneously for patients who have moderately to severely active Ulcerative Colitis.

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

Ulcerative Colitis (UC) is a chronic inflammatory disease affecting the mucosal lining of the colon and rectum and the incidence is increasing, but the etiology remains unknown. Patients may require a proctocolectomy due to refractory disease. Prior to an operation, UC is treated with antibiotic therapy, immunomodulatory therapy and immunosuppressive agents. While there is an increasing number of approved biologics for the treatment of UC, there are many patients that still suffer from refractory disease. Thus, alternative mechanisms of therapy are desperately needed.

Treatments that have the potential to reduce mucosal inflammation could alleviate the pathology of luminal UC. This trial ...

The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with rectovaginal fistulizing Crohn's disease. Autologous means that these cells that coat the plug come from you. You will be in this study for two years. There is potential to continue to monitor your progress with lifelong regular visits as part of your standard of care. All study visits take place at Mayo Clinic and Rochester, MN. The study visit schedule is as follows: Visit 1 (Week -6) - Screening visit: exam under anesthesia and surgery to ...

The purpose of this study is to demonstrate the impact of an Adult Inflammatory Bowel Disease (IBD) learning health system approach that enables patients and their care teams to coproduce optimal health and high value care.

To evaluate a new oral treatment, ABI-M201 (or placebo) in individuals with mild to moderate Ulcerative Colitis who have sustained an inadequate response to ongoing mesalamine treatment.

Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 72 weeks of open-label treatment to evaluate the long-term safety of the drug.

The purpose of this study is to evaluate effectiveness of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.

The objective of this study is to evaluate the efficacy and safety of Upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

This study is designed to evaluate the long-term safety and efficacy of ABT-494 in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 (Substudies 1 and 2), who have had loss of response during the maintenance period of Study M14-234 (Substudy 3), or who have successfully completed Study M14-234.

The primary purpose of this study is to evaluate the effectiveness of Apraglutide (5 mg subcutaneously (SC), once weekly) in reducing the administered volume per week of PS from baseline, compared with placebo in adults with Short Bowel Syndrome and Intestinal Failure.

Short bowel syndrome is a malabsorptive condition characterized by extreme reduction in functional small intestinal length most commonly as a result of surgical resection due to mesenteric ischemia or Inflammatory Bowel Disease (IBD) although other etiologies are also present. 

The purpose of this study is to create a group of blood and urine samples and quality of life data from Mayo Clinic patients with a diagnosis of inflammatory bowel disease (IBD). The blood and urine samples and quality of life data will be used for future research of IBD at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.

The purpose of this study is to collect and annotate PEG (Phonoenterogram) data from healthy volunteers, patients with irritable bowel syndrome (IBS), patients with inflammatory bowel disease (IBD),post-surgical patients with an increased risk of developing paralytic postoperative ileus (POI), and patients with evidence of partial bowel obstruction for facilitating the technical development of the PEG-CAAe using Artificial Intelligence.

The focus of this study is to retrospectively examine the patterns of use of biological agents and risk factors for discontinuation of these agents in pediatric Crohn’s disease (CD) and ulcerative colitis (UC) within the ICN network.  This will be a retrospective longitudinal observational cohort study.  The study population for the first portion of the study (Aim 1a below) will be all CD and UC patients in ICN who were diagnosed with IBD prior to age 18. This population will be queried for biologic use prior to age 18. The study population for the remainder of the study will be ...

The purpose of this research study is to collect clinical information and human samples from patients with IBD. The data collected will be used to create an organized, accessible resource of human samples for biological research in IBD.

The purpose of this study is to assess the effectiveness and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52 weeks.

The focus of the proposed study is to improve understanding of the underlying mechanisms of symptom burden, and the purpose is to describe how sleep health contributes to symptoms and functional performance in adults with Inflammatory Bowel Disease (IBD).

We would like to collaborate and further develop an ipad-based, interactive quiz game 'Emma'; to identify gaps in knowledge of inflammatory bowel disease in pediatric patients. These gaps can be used to improve patient education.

The purpose of this study is to determine whether AVB-114 compared to standard of care treatment is effective in inducing remission of the treated complex perianal fistula in subjects with Crohn’s Disease. It also aims to assess clinical and radiologic components of fistula remission, safety of treatment, disease activity, patient Quality of Life, and patient care journey, between AVB-114 and standard of care treatment.

The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active ulcerative colitis or Crohn's disease.

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of 20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton with continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore® Bio-A® fistula plug as per current clinical practice. ...

The purpose of this study is to assess the effectiveness and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52 weeks.

Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications ...

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with SHP647 in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD).

The purpose of this research study is to assess women who are diagnosed with Inflammatory Bowel Disease (IBD) and study the combination of using usual medical treatment with a wellness program designed just for women with IBD and the effect it has on quality of life, stress, and their symptoms

The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent patients.

The purpose of this study is to assess the effectiveness and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52 weeks.

The purpose of this study is to evaluate the long-term safety of a single dose of darvadstrocel in participants with Crohn's disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).

The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with fistulizing Crohn's disease. Autologous means these cells to coat the plug come from the patient.

This study will be a multi-center, longitudinal, observational investigation to collect biospecimens (blood, stool and intestinal biopsies) to support the development of specific biomarkers of treatment response to infliximab and vedolizumab in children with IBD.

The purpose of this study is to collect blood and stool samples to validate and improve the performance of stool and blood DNA markers for inflammatory bowel disease and colorectal neoplasia critical to the long-term goal of improving effectiveness of neoplasia detection in patients using non-invasive biomarkers to assist colonoscopy and radiographic screening. 

The purpose of this study is to determine the performance of the Exact IBD-ACRN (inflammatory bowel disease-advanced colorectal neoplasia)surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease. Enrolled subjects must have undergone colonoscopy no more than 90 days prior to enrollment, will collect a stool sample for the surveillance test and then must undergo colonoscopy or surgical intervention within 120 days after enrollment.

The purpose of this study is to understand the impact of the COVID pandemic on IBD patients, including infection rates and complications from SARS-COV2, IBD related flares, patient compliance with biologic agents, impact of lockdowns on access to IV infusion centers, need for steroid therapy and admissions for IBD related flares, and modification of medical management.

The purpose of this study is to determine if WATS 3D (The Wide Area Transepithelial Sample with three dimension analysis) can be used to adequately sample the colon and identify dysplasia in patients with Irritable Bowel Disease (IBD) undergoing surveillance. 

The purpose of the study is to:

• Map and compare the neoplasia-associated epigenetic field in IBD-CRN, sporadic CRN and controls.  
• Measure sensitivity of DNA methylation for the detection of synchronous IBD-CRN as a complement or alternative to histologic diagnosis of dysplasia on random biopsies. 
• Measure the density and types of lymphocytes infiltrating IBD-CRN tumors, sporadic tumors and the epigenetic field. 

This will be a prospective study of patients with IBD at Mayo Clinic initially in Jacksonville with possible subsequent extension to other Mayo sites.  We will evaluate the immunogenicity of commercially available COVID-19 vaccines and compare vaccine response among the groups based on their immunosuppressive regimens.  We will divide the immunosuppressive regimens into presumed high vaccine responders Group A and presumed low vaccine responders Group B. We will also assess for adverse reactions to the vaccine and compare with the reported rates in the clinical trials that led to approval of these vaccines.

Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications ...

Primary Aim

            We aim to evaluate: 1) the correlation between patient-reported rectal bleeding and stool frequency and health-related quality of life focused on fatigue, depression and anxiety, and work productivity; and 2) the correlation between the severity of endoscopic inflammation and health-related quality of life focused on fatigue, depression and anxiety, and work productivity.

Secondary Aims

We also aim to evaluate the correlation between the combination of clinical/PRO and the severity of endoscopic inflammation and health-related quality of life focused on fatigue, depression and anxiety, and work productivity.

The purpose of this study is to see if whole blood-based blood biomarker (i.e., cytokine) predicts status and severity of diseases such as asthma, Juvenile Idiopathic Arthritis (JIA), Rheumatoid Arthritis (RA), or Inflammatory Bowel Disease (IBD).