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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights

TIARSCeD Trial 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.Check my eligibility
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.See study design
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.

TIARSCeD Trial 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.

TIARSCeD Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Erythrocyte Indices
Secondary outcome measures
Gastrointestinal Symptoms Rating Scale (GSRS)
Hospital Anxiety and Depression Scale (HADS)
Duodenum
+1 more
Other outcome measures
Duodenum
Duodenal mucosal villus-crypt ratio (VCR)
Tissue transglutaminase IgA (tTG) titres

TIARSCeD 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.

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
884 Previous Clinical Trials
2,598,266 Total Patients Enrolled
4 Trials studying Celiac Disease
240 Patients Enrolled for Celiac Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project include participants of 45 years or older?

"Individuals aged 18 or over, but younger than 75 years old are eligible to participate in this trial."

Answered by AI

What type of individuals is this clinical trial seeking as participants?

"To qualify for this medical trial, individuals must be diagnosed with celiac disease and between 18-75 years old. The study team is seeking to enrol 50 participants in total."

Answered by AI

Is this medical study currently recruiting participants?

"Affirmative. Clinicaltrials.gov data confirms that this research project, which first appeared on December 1st 2022, is recruiting volunteers actively. The team behind the trial are hoping to enlist 50 participants from a single medical centre."

Answered by AI

What is the upper limit of trial participants for this research project?

"Correct. According to the date on clinicaltrials.gov, this ongoing medical trial was initially shared with the public on December 1st 2022 and has since been updated in October 12th 2023. The study requires 50 patients from a single location for participation."

Answered by AI

Who else is applying?

What site did they apply to?
McMaster University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Tryptophan for Impaired AhR Signaling in Celiac Disease
David Armstrong 2022. "Tryptophan for Impaired AhR Signaling in Celiac Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05576038.
All > Celiac Disease
~13 spots leftby Nov 2024
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