Coeliac Disease Trial, Recruiting NCT05576038 Sponsor: McMaster University Condition: Coeliac Disease
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Coeliac Disease Trial, Recruiting

NCT05576038
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 75 years old
  • You have been diagnosed with celiac disease, confirmed by both a positive intestinal biopsy and a positive blood test (anti-tTG IgA)
  • You still have ongoing celiac disease symptoms (scoring above 40 on a celiac symptom questionnaire) even after following a strict gluten-free diet for more than one year

Who may not be able to join:

  • You currently take acid-reducing or antacid medications
  • You have taken antibiotics, antibacterial medicines, or probiotics in the last 8 weeks
  • You have another ongoing gut condition or autoimmune disease, such as inflammatory bowel disease or type 1 diabetes
  • You have lactose intolerance or fructose intolerance
  • You have previously had weight-loss surgery, stomach surgery, or a surgical procedure involving the upper digestive tract
  • You have a connective tissue disease (a condition affecting tissues that support and connect the body, such as lupus — confirm with trial site)
  • You have another active digestive condition beyond certain minor ones (confirm with trial site)
  • You are on long-term, high-dose opioid pain medication
  • You have a current problem with alcohol or drug misuse
  • You have another serious illness or abnormal lab results that the research team believes could affect your safety or the study results
  • You are allergic or sensitive to any ingredient in the study medication or placebo
  • You currently take lithium or a type of antidepressant called monoamine oxidase inhibitors (MAOIs)
  • You have taken part in another dietary treatment study within the last 4 weeks

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 905 521-2100

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
McMaster University
Registry
ClinicalTrials.gov
Start date
1 December 2022
Est. completion
1 April 2025

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Measurement of Celiac Symptom Index (CSI)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov