Tryptophan for Impaired AhR Signaling in Celiac Disease

Launched by MCMASTER UNIVERSITY · Oct 7, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether a supplement called L-tryptophan can help improve symptoms in people with celiac disease who are still experiencing issues despite following a gluten-free diet for over a year. The study will include 50 participants aged between 18 and 75 years who have been diagnosed with celiac disease and have high symptom scores indicating ongoing discomfort. Participants will be randomly assigned to receive either the L-tryptophan supplement or a placebo (a pill with no active ingredients) for three weeks, and neither the participants nor the researchers will know who is receiving which treatment during this time.

To be eligible for the trial, participants must have a confirmed diagnosis of celiac disease and report persistent symptoms, scoring above 40 on a specific symptom index. Certain individuals cannot participate, including those taking specific medications, with other gastrointestinal diseases, or who have allergies to the study's components. This trial is currently recruiting participants, and it provides a chance to explore a new potential treatment for those struggling with their celiac disease symptoms.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 18 and 75 years of age
• • Celiac disease (CeD) diagnosis: Individuals with histological and serological evidence of CeD serology (positive biopsy and anti-tTG IgA)
• • Persistent CeD related symptoms (\>40 on the Celiac Symptom Index) despite \>1 year of a gluten free diet (GFD)
• Exclusion criteria:
• • Acid anti-secretory and antacid medications
• • Antibiotics, antibacterial agents or probiotics, currently, or within the last 8 weeks
• • Current organic gastrointestinal or other autoimmune diseases, such as inflammatory bowel disease or diabetes mellitus (type 1)
• • Lactose and/or fructose intolerance
• • History of bariatric surgery, fundoplication or gastrectomy (partial or complete)
• • Connective tissue disease
• • Concurrent organic GI pathology other than benign polyps, haemorrhoids, lipomas, Helicobacter pylori infection, diverticulosis and melanosis coli
• • Chronic treatment with high dose opioids
• • Alcohol or drug abuse
• • Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be a risk or that could interfere with data collection
• • Allergy or sensitivity to any component of the study medication or placebo
• • Use of lithium and monoamine oxidase inhibitors (MAOIs)
• • Participation in another dietary treatment study within the last 4 weeks