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Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients
This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening.
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PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).
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PTG-100 for Patients With Celiac Disease
The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten. This is a clinical research study to determine the safety and efficacy of PTG-100 in preventing gluten-induced inflammatory injury to the small intestine in patients with celiac disease. 30 patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. They will also receive a gluten challenge twice daily in the form of a cookie or equivalent. An upper gastrointestinal...
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Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity
Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis. Some studies seem to suggest that wheat components other than gluten (i.e. amylase/trypsine inhibitors, ATIs) can cause the symptoms, and therefore the term "non-celiac wheat sensitivity" (NCWS) has been proposed instead of NCGS. It is believed that this condition is worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with high gluten...
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Safety and Efficacy of Fecal Microbiota Transplantation
The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies. Recent studies have suggested that dysbiosis is associated with...
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Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.
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Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity
Investigator initiated, randomised, placebo-controlled, double-blind, multi-centre primary intervention study to assess whether daily administration of B. infantis EVC001 from age 7 days to 6 weeks (+14 days) until age 12 months (+ 14 days) to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood.
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T Cell Receptor (TCR) Sequencing and Transcriptional Profiling in Adult Celiac Disease Patients Undergoing Gluten Challenge
The primary objectives are: - Characterize the T cell receptor (TCR) repertoire in duodenal biopsy samples of participants pre- and post-challenge. - Compare for each patient the TCR repertoire of duodenal biopsy samples with the peripheral blood TCR repertoire of each study participant - Characterize the transcriptome of duodenal biopsy samples and blood from study participants pre- and post-challenge The secondary objectives are: - Ex vivo identification and validation of DQ-restricted gliadin specific TCRs. - Characterize the gluten-challenge induced changes in small...
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Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease
The investigators will see if the drug teriflunomide (which is in use in other immune disorder (multiple sclerosis)) can inhibit the immune activation in celiac disease patients during a 3 day gluten challenge. This will be measured in a blood sample.
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Urinary Gluten Immunogenic Peptides Detection in Non-celiac Gluten/Wheat Sensitivity
Non-celiac gluten/wheat sensitivity (NCGS/NCWS) is a syndrome characterized by both intestinal (irritable bowel syndrome [IBS]-like presentation) and extraintestinal symptoms (headache, migraine, "foggy mind", depression, anxiety, fibromyalgia, joint and muscle pain, leg or arm numbness, eczema or skin rash), which occur after the ingestion of gluten/wheat in subjects in which celiac disease (CD) and wheat allergy diagnosis has been previously excluded. NCGS/NCWS symptoms generally occur after the ingestion of gluten/wheat, disappear within a few days of a gluten-free diet (GFD) and quickly reappear when gluten/wheat is reintroduced....
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