Clinical Trials

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of VTP-1000 to define a dose and schedule for further investigation.

This study will assess the effect of gluten on gut barrier function. Investigators at the Mayo Clinic have developed a new gut permeability test using rhamnose (sugar & water solution), and are hoping to prove its effectiveness in a clinical setting.

The purpose of this study is to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) who are on a gluten free diet (GFD) with and without simulated inadvertent gluten exposure (SIGE).

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 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 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 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 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.

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 Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).

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.

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 evaluate the human leukocyte antigen (HLA)-DQ 2.5+ in adults with celiac disease (CeD).

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of DONQ52 in celiac disease patients and to evaluate the safety and tolerability of DONQ52 in celiac disease patients in the presence of gluten after multiple doses of DONQ52.

Furthermore, to characterize the DONQ52 PK profile following single and multiple subcutaneous (SC) dose(s) in celiac disease patients and to investigate the immunogenicity of DONQ52.

This study is a randomized, double-blind, placebo controlled clinical study to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of FB102 in adult participants with well controlled (on a strict GFD) CeD following an oral gluten challenge.

The primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease.

The primary safety objective of the trial is to assess the safety of TEV-53408 in adults with celiac disease.

A secondary objective is to further assess the efficacy of TEV-53408 in adults with celiac disease.

The expected trial duration per participant is approximately 86 weeks.

The goal of this project, to develop a simple and sensitive test of small bowel permeability, will improve the scientific and public health understanding of environmental enteropathy and guide development of preventative and treatment modalities such as clean water and sanitation.

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 see if advanced endoscopic imaging may be helpful to accurately distinguish pathological tissue from normal tissue and guide therapy of endoscopically identified pathology.

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.