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โ† Trials
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Tryptophan for Impaired AhR Signaling in Celiac Disease

RecruitingNAAges 18 Years - 75 YearsAllMcMaster University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • L-Tryptophan
  • Freedom SimpleCap Powder
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Where

1 site
McMaster University
Hamilton, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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