Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial involved 12 participants, all of whom had been infected with a small number of *Necator americanus* hookworms and then exposed to increasing amounts of gluten over time. The trial was broken into three stages — a tiny gluten exposure, a low-dose gluten challenge, and a high-dose gluten challenge — with all 12 participants completing the first stage, 10 completing the second, and 8 completing the third. The study was primarily measuring whether the lining of the small bowel (the gut's inner wall) stayed intact during gluten exposure, using a measurement called the villus height to crypt depth ratio — essentially a way of comparing the height of tiny finger-like projections in the gut lining to the depth of the pits between them. A lower ratio can indicate gut damage. The reported data shows that the primary gut lining measurement (villus height to crypt depth ratio) was recorded as 2.73 at two separate time points for the group. For the secondary outcomes, immune cells in the gut lining (called intraepithelial lymphocytes, which tend to increase when the gut is reacting to gluten) were reported at 33.40% and 35.00% at two time points. A separate scoring system for gut inflammation (the Marsh score, where higher numbers indicate more severe changes) showed that 1 participant had a meaningful worsening of their score after the low-dose gluten challenge. Additionally, a blood marker linked to coeliac disease activity (anti-tissue transglutaminase antibodies, where levels below 15 units/mL are considered normal) was reported at three time points: 4.12, 2.99, and 2.11 units/mL — all below the normal cut-off threshold used in the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 21408161) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Coeliac Disease Trial, Completed
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 an adult who previously took part in a related study where you were given an experimental hookworm infection, and you also have celiac disease that is being managed through your diet.
Who may not be able to join:
- You are currently taking medications or receiving treatments that suppress or weaken your immune system.
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.
Contact this trial
Principal Investigator: John Croese, MD, The Prince Charles Hospital, Centre for Biodiscovery and Molecular Development of Therapeutics
Australian sites
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
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Duodenal Villus Height:Crypt Depth
Can't join this trial?
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.