Tryptophan for Impaired AhR Signaling in Celiac Disease
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Tryptophan Metabolism Alterations, Celiac Disease
In brief
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.
Key facts
- Study ID
- NCT05576038
- Run by
- McMaster University
- People needed
- 50
- Starts
- 2022-12-01
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2025-01-10
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- McMaster University — Hamilton, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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