Tryptophan for Impaired AhR Signaling in Celiac Disease

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Treatments: Tryptophan

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