Tryptophan for Impaired AhR Signaling in Celiac Disease (TIARSCeD)
Tryptophan Metabolism Alterations, Celiac Disease
About this trial
This is an interventional treatment trial for Tryptophan Metabolism Alterations focused on measuring Tryptophan, Celiac disease, Aryl Hydrocarbon Receptor
Eligibility 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
Sites / Locations
- McMaster UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
L-Tryptophan
Freedom SimpleCap Powder
L-tryptophan* supplements (Tryptan, Valeant Canada LP): each treatment capsule contains 500 mg of L-Tryptophan; talc and magnesium stearate. Study participants will be instructed to take 2 x 500 mg capsules (1000 mg) every 8 hrs, three times a day. (total daily dose: 3000 mg) for a total of 3 weeks. Instructions will be printed on the label of the pill container.
500 mg of SimpleCap Powder. Study participants will be instructed to take 2 x 500 mg capsules (1000 mg) every 8 hrs, three times a day. (total daily dose: 3000 mg) for a total of 3 weeks. Instructions will be printed on the label of the pill container.