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Tryptophan for Impaired AhR Signaling in Celiac Disease

Celiac Disease | Tryptophan Metabolism Alterations

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 75

Participation 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

Study Location

McMaster University
McMaster University
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

David Armstrong

Study Sponsored By
McMaster University
Participants Required
More Information
Study ID: NCT05576038