L-tryptophan supplementation for celiac disease symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effects of L-tryptophan supplementation on individuals with biopsy-confirmed celiac disease who continue to experience symptoms despite following a gluten-free diet for over a year. Fifty participants aged 18 to 75 will be randomly assigned to receive either L-tryptophan or a placebo for three weeks. Participants will also receive dietary counseling to maintain a low tryptophan, gluten-free diet, and their compliance will be monitored through dietary recalls. The study will assess symptom changes and collect various biological samples to understand the impact of the intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• McMaster University
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Gaston H Rueda, MD
• Email: ruedag@mcmaster.ca
• Phone: 905 521-2100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.