Joseph A. Murray, M.D.

The purpose of this study is to compare the number of baseline interferon-gamma (IFN-γ) spot forming units (SFUs) to the number of IFN-γ SFUs after a 6-day oral gluten challenge among HLA DQ2–positive subjects treated with TAK-101 versus placebo.

The purpose of this study is to develop a resource (bank) of biospecimens (blood, tissue, stool) and data collected from individuals with known or suspected gluten enteropathy, including celiac disease (CD) and dermatitis herpetiformis (DH).  Other enteropathies will also be included: collagenous sprue, idiopathic sprue, lymphocytic enterocolitis, idiopathic enteropathies, collagenous gastritis, Whipple’s disease, and other miscellaneous inflammatory disorders of the small intestine. This resource will be invaluable in answering the important questions outlined above and other future unanswered questions.   

The purpose of this study is to address critical gaps in our understanding of celiac disease (CeD) pathogenesis and clinical presentations. Additionally, to test the hypothesis that interactions between IECs, microbiota, immune system, genetics and gluten underlie differences in clinical presentation, severity of tissue destruction, and ability to heal, and to generate resources and hypotheses to advance patient care.

The purpose of this study is to demonstrate a positive correlation of histologic protection (biological signature) and symptom protection (clinical outcome) for latiglutenase treatment versus placebo in Celiac Disease (CD) patients undergoing a deliberate gluten challenge.

This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a gluten free diet (GFD) for at least one year prior to screening.

The purpose of this study is to assess the safety and tolerable of single and multiple doses of KAN-101 in patients with Celiac disease.

The purpose of this study is to evaluate the safety, tolerability, and activity of escalating doses of AK002 in patients with Eosinophilic Gastritis (EG) and/or Eosinophilic Gastroenteritis (EGE).

The purpose of this study is to evaluate the safety and tolerability of AK002 in patients with mast cell gastritis and/or gastroenteritis, examine changes in number of mast cells/HPF in gastric and duodenal biopsies, examine any change in gastrointestinal symptom score as estimated by a daily patient-reported outcome (PRO) questionnaire and look for any changes in absolute peripheral blood eosinophil counts.

The purpose of this study is to evaluate the human leukocyte antigen (HLA)-DQ 2.5+ in adults with celiac disease (CeD).

The purpose of this study is to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric and/or duodenal biopsies before and after receiving AK002 or placebo versus no difference between AK002 and placebo control (null hypothesis).

This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric and duodenal biopsies before and after receiving AK002 or placebo versus no difference between AK002 and placebo control (null hypothesis).

The purpose of this study is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.

The purpose of this study is to evaluate the effectiveness and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).

The purpose of this study is to generate open-label, longer-term safety, tolerability, and effectiveness follow-up data in patients with EG and/or EoD who completed Study AK002-016 or Study AK002-012.

The purpose of this study is to evaluate the effectiveness and safety of 4 doses of AK002 in patients with moderate to severe EG and/or EGE when compared to placebo.

The purpose of this study is to assess the effectiveness and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

The purpose of this study is to evaluate participants for immune responses and histological changes in the small bowel following 2 doses of TIMP-GLIA or placebo and a 14-day oral gluten challenge.

The aim of this study is to the number of individuals following a gluten-free diet and possible reasons including symptoms of non-celiac gluten sensitivity and functional gastrointestinal diseases (FGIDs). lso assess Diagnoses and lab values associated with celiac disease, NCGS, and FGIDs will also be assessed, as well as past GI survey data and medical record data available through the Rochester Epidemiology Project.

To obtain biopsies and blood from subjects not previously known to have celiac disease who are undergoing duodenal biopsies for clinical indications. The subjects will have no prior diagnosis of celiac disease and are eating a gluten-containing diet. The biopsies will be treated “in vitro” with enzymatic digests of gluten derived from bread made from different species of wheat, the auto-antigen tTg, cytokines, or other proteins.

The purpose of this study is to determine if people with diarrhea predominant IBS (IBS-D) from the community are interested in making dietary modifications to control their symptoms.  Also to determine if people with IBS-D from the community have tried dietary modifications to control their symptoms and if they have, which diets they have tried.

Background:

• Celiac disease is a condition where the immune system attacks the cells of the small intestine. The intestine becomes inflamed and cannot digest food properly. The disease most often causes a reaction to foods that contain gluten. Most people can treat celiac disease with a gluten-free diet. However, some people have digestion problems even on a gluten-free diet. Researchers want to try a new antibody therapy for celiac disease. The treatment may block the immune reaction that causes the disease. They will test this antibody in people who have celiac disease that has not responded to a gluten-free diet.

Objectives:

• To see if antibody therapy is a safe and effective treatment for celiac disease that has not responded to standard treatments.

Eligibility:

• Individuals at least 18 years of age who have been on a gluten-free diet for 6 to 12 months but still have symptoms of celiac disease.

Design:

• Participants will be screened with a physical exam and medical history. Blood samples will be collected. These samples will help determine if the specific antibody treatment is likely to work.
• Before the start of the study, participants will have a biopsy of the small intestine.
• Participants will receive three doses of the study antibody as injections. These doses will be given 3 weeks apart.
• Treatment will be monitored with blood tests and heart function tests. Participants will also have a second small intestine biopsy within a week after the last dose of the antibody.

The relationship or effect of food antigen (wheat based soy sauce) in eosinophilic esophagitis. It is believed that when food antigens are exposed to the esophageal tissue it starts an chronic allergy-based inflammation. This will be analyzed with the esophageal biopsies and the mucosal impedance probe.

This purpose of this study is to determine if activation of a person's immune system in the small intestine could be a contributing cause of Type 1 Diabetes.

The purpose of the study is to assess the connection between simvastatin metabolism by an enzyme that varies based on the state of the small intestine in treated celiac disease.

The purpose of this study is to identify mediators—innate immune system and intestinal permeability—of acute onset gastrointestinal symptoms after gluten ingestion in subjects with celiac disease and non-celiac gluten sensitivity.