Actively Recruiting
Tryptophan for Impaired AhR Signaling in Celiac Disease
Led by McMaster University · Updated on 2025-01-10
50
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tryptophan for Impaired AhR Signaling in Celiac Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with celiac disease confirmed by biopsy and serology (positive anti-tTG IgA)
- Persistent celiac disease symptoms scoring above 40 on the Celiac Symptom Index
- Following a gluten-free diet for more than 1 year with ongoing symptoms
You will not qualify if you...
- Use of acid anti-secretory or antacid medications
- Use of antibiotics, antibacterial agents, or probiotics currently or within the last 8 weeks
- Presence of organic gastrointestinal or other autoimmune diseases such as inflammatory bowel disease or type 1 diabetes
- Lactose or fructose intolerance
- History of bariatric surgery, fundoplication, or gastrectomy
- Connective tissue diseases
- Other organic gastrointestinal conditions except benign polyps, hemorrhoids, lipomas, Helicobacter pylori infection, diverticulosis, or melanosis coli
- Chronic high-dose opioid treatment
- Alcohol or drug abuse
- Concurrent systemic diseases or lab abnormalities posing risk or interfering with data collection
- Allergy or sensitivity to study medication or placebo components
- Use of lithium or monoamine oxidase inhibitors (MAOIs)
- Participation in another dietary treatment study within the last 4 weeks
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
McMaster University
Hamilton, Ontario, Canada, L8N3Z5
Actively Recruiting
Research Team
G
Gaston H Rueda, MD
CONTACT
U
Utkarshini N Kirtikar, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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