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Amino Acid Supplement

Tryptophan for Celiac Disease (TIARSCeD Trial)

N/A

Recruiting

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Celiac disease (CeD) diagnosis with histological and serological evidence of CeD serology (positive biopsy and anti-tTG IgA)

Age between 18 and 75 years

Must not have

Current organic gastrointestinal or other autoimmune diseases, such as inflammatory bowel disease or diabetes mellitus (type 1)

Use of lithium and monoamine oxidase inhibitors (MAOIs)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Summary

This trial explores how L-tryptophan supplements affect celiac-related symptoms in those who have CeD and don't feel better with a GFD. 50 people aged 18-75 with persistent symptoms will test it.

Who is the study for?

This trial is for adults aged 18-75 with celiac disease who still have symptoms despite following a gluten-free diet for over a year. Participants must have confirmed celiac disease with specific tests and score above 40 on the Celiac Symptom Index. People taking certain medications, those with other autoimmune or systemic diseases, gastrointestinal issues besides benign conditions, recent participants in dietary studies, substance abusers, and individuals with lactose/fructose intolerance cannot join.

What is being tested?

The study is testing if L-Tryptophan supplements can help reduce symptoms of celiac disease that persist even after following a gluten-free diet. Half of the participants will receive L-Tryptophan while the other half will get a placebo without knowing which one they're taking (double-blind). The treatment period lasts for three weeks.

What are the potential side effects?

Potential side effects from L-Tryptophan may include digestive discomfort, mood changes like irritability or sadness, sleepiness or insomnia, headaches and dry mouth. However, individual reactions to supplements can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with celiac disease confirmed by a biopsy and blood test.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have conditions like inflammatory bowel disease or type 1 diabetes.

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I am not taking lithium or MAOIs.

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I have had weight loss surgery or surgery on my stomach.

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I have not used antibiotics, antibacterial agents, or probiotics in the last 8 weeks.

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I have a connective tissue disease.

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I am on long-term high dose pain medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Erythrocyte Indices

Secondary study objectives

Gastrointestinal Symptoms Rating Scale (GSRS)

Hospital Anxiety and Depression Scale (HADS)

Duodenum

+1 more

Other study objectives

Duodenum

Duodenal mucosal villus-crypt ratio (VCR)

Tissue transglutaminase IgA (tTG) titres

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: L-TryptophanActive Control1 Intervention

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.

Group II: Freedom SimpleCap PowderPlacebo Group1 Intervention

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.

0 / 8Eligibility criteria met