NCT05576038 Tryptophan for Impaired AhR Signaling in Celiac Disease
| NCT ID | NCT05576038 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McMaster University |
| Condition | Tryptophan Metabolism Alterations |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2022-12-01 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, randomized, double-blind, placebo-controlled exploratory trial to evaluate the effect of L-tryptophan supplementation on celiac-related symptoms in individuals who have biopsy-confirmed celiac disease (CeD) and symptoms non-responsive to a gluten-free diet (GFD). Fifty participants, aged 18 to 75 years, who self-report persistent CeD-related symptoms despite taking a GFD for more than 1 year and who score \> 40 on the Celiac Symptom Index (CSI) will be randomized to receive L-tryptophan or placebo for 3 weeks.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05576038 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Tryptophan Metabolism Alterations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05576038 currently recruiting?
Yes, NCT05576038 is actively recruiting participants. Contact the research team at ruedag@mcmaster.ca for enrollment information.
Where is the NCT05576038 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT05576038 clinical trial?
NCT05576038 is sponsored by McMaster University. The trial plans to enroll 50 participants.