Coeliac Disease Trial, Recruiting NCT05680012 Sponsor: University of Chicago Condition: Coeliac Disease
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Coeliac Disease Trial, Recruiting

NCT05680012
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:

This trial has three separate groups, each with different requirements:

Gluten Challenge Group (people with celiac disease who eat gluten-free):

  • You are between 18 and 75 years old
  • You were diagnosed with celiac disease by an intestinal biopsy at least 12 months ago
  • You have been strictly following a gluten-free diet for at least the past 12 months in a row

Gluten De-challenge Group (people with celiac symptoms not on a gluten-free diet):

  • You are between 18 and 75 years old
  • You are currently experiencing typical celiac disease symptoms
  • You are not currently following a gluten-free diet

Control Group (general participants):

  • You are between 18 and 75 years old
  • If you are female, you are not currently pregnant

Who may not be able to join:

Gluten Challenge Group:

  • You have been diagnosed with a serious complication of celiac disease
  • You have another long-term, active digestive or gut disease
  • You have a specific immune system condition affecting a protein called IgA (confirm with trial site)
  • You have had a severe reaction after being exposed to gluten
  • You have any other significant health conditions
  • You have a history of serious alcohol or substance misuse
  • You are pregnant or breastfeeding
  • You have a blood clotting disorder

Gluten De-challenge Group:

  • You have a history of long-term inflammatory gut disease
  • You have had a gut or stomach illness in the four weeks before screening
  • You have a history of a condition affecting certain blood or lymph cells (confirm with trial site)
  • You have an uncontrolled blood clotting disorder
  • You have any other significant health conditions
  • You have a history of serious alcohol or substance misuse

Control Group:

  • You are currently taking antibiotics, stomach acid-reducing medication (such as omeprazole), aspirin, or anti-inflammatory painkillers (such as ibuprofen)
  • You have a known condition causing inflammation in your gut or intestines
  • You have previously had surgery on your digestive system
  • You are taking blood-thinning or anti-clotting medications
  • A close family member has been diagnosed with celiac disease

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

Principal Investigator: Bana Jabri, MD, University of Chicago

Phone: (773) 834-1438

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
Registry
ClinicalTrials.gov
Start date
14 July 2023
Est. completion
1 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Gluten challenge group: quantitative analysis of intestinal villus to crypt ratios; Gluten de-challenge group: quantitative analysis of intestinal villus to crypt ratios

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