Current Clinical Celiac Disease Trials at the Mayo Clinic

Celiac.com 02/28/2024 - We get a lot of questions about what celiac disease trials and studies are going on, but there are so many, it can be hard to keep track. One easy source is the Mayo Clinic, which is at the forefront of a number of research trials, and studies to better understand, and treat celiac disease. Currently, there are more than a dozen exciting clinical trials underway, each focusing on different aspects of the celiac disease. 

One study aims to assess the effect of gluten on gut barrier function by using a novel gut permeability test developed by Mayo Clinic researchers. Another trial is evaluating the safety and tolerability of a potential new treatment, KAN-101, for celiac disease patients. 

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Additionally, researchers are investigating the effectiveness and safety of numerous compounds for relieving symptoms in adult celiac disease patients. 

These trials represent important steps forward in advancing our understanding of celiac disease and developing new therapies to improve the lives of those affected by this condition. 

Celiac disease trials and studies currently underway at the Mayo Clinic facilities include:

Gut Permeability Assessment in Celiac and Gluten Sensitive Children
Rochester, MN

• 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.

A Study to Assess the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Celiac Disease Patients
Rochester, MN

• 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.

A Study to Evaluate the Effectiveness and Safety of Larazotide Acetate for the Relief of celiac disease Symptoms
Rochester, MN

• 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.

Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
Rochester, MN

• 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.

A Study of the Response to and Changes in Intestinal Permeability 4 hours after a Gluten Challenge in Subjects with Celiac Disease and Non Celiac Gluten Sensitivity
Rochester, MN

• 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.

Gut Permeability in Environmental Enteropathy
Rochester, MN

• 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.

Mucosal Interactions in Celiac Disease
Rochester, MN

• 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.

A Study to Evaluate the Safety, Effectiveness, and Tolerability of Latiglutenase to Treat Patients with Well-Controlled Celiac Disease
Rochester, MN

• 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 (celiac disease) patients undergoing a deliberate gluten challenge.

A Study of the Safety, Pharmacodynamics, Effectiveness, and PK of TIMP-GLIA in Subjects with Celiac Disease
Rochester, MN

• 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.

Dose-Ranging Study of the Efficacy and Safety of TAK-101 for Prevention of Gluten-Specific T Cell Activation in Participants With Celiac Disease on a Gluten-Free Diet
Rochester, MN

• 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.

A Study of Simvastatin Metabolism as a Test for Celiac Disease Activity
Rochester, MN

• 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.

Antibody Treatment for Advanced Celiac Disease
Rochester, MN

• 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.

Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic Celiac Disease Patients
Rochester, MN

• This is a phase 2b, multi-center, 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.

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
Rochester, MN; Scottsdale/Phoenix, AZ

• 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 (celiac disease) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.

A Study of the Safety, Effectiveness and Tolerability of Nexvax-2 in Patients with Celiac Disease (celiac disease)
Rochester, MN

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

Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

• To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.

Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim
Jacksonville, FL; Rochester, MN

• 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.

Functional Gastrointestinal Disease, Celiac Disease, and Non-celiac Gluten Sensitivity in an Olmsted County Cohort
Rochester, MN

• 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.

Stay tuned for updates on the progress of these and other related studies!

Read more at Mayo.edu