Investigating the effects of partially hydrolyzed gluten on celiac disease patients
Towards Comprehensive Analytical Methods for Partially Hydrolysed Gluten to Assess Product Safety for Celiac Disease Patients
This study tests how different types of gluten affect people with celiac disease to help make gluten-free products safer for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 2 sites (Mainz and 1 other locations) |
| Trial ID | NCT06151782 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the immune responses of patients with celiac disease (CeD) to high doses of wheat and barley gluten, as well as low doses of barley gluten and hydrolyzed malted barley. Participants will undergo four one-day gluten challenges spaced four weeks apart. The research focuses on understanding the immunogenicity of different gluten forms to ensure the safety of gluten-free products for CeD patients. By employing advanced proteomics and functional assays, the study seeks to provide better insights into gluten safety for individuals with CeD.
Who should consider this trial
Good fit: Ideal candidates include individuals with biopsy-verified celiac disease who have been on a strict gluten-free diet for at least 24 months and are sensitive to gluten.
Not a fit: Patients who are pregnant, lactating, or have other significant health conditions such as Type 1 diabetes or inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary options for celiac disease patients by confirming the safety of partially hydrolyzed gluten in their diets.
How similar studies have performed: While the approach of assessing gluten immunogenicity is established, the specific focus on partially hydrolyzed gluten in celiac disease patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI between 18 and 30 kg/m2 * Biopsy verified celiac disease * Pos gene test for HLA-DQ2.5 or DQ8 * Strict glutenfree diet for at least 24 months * Clinical remission * Sensitive to gluten by accidental intake * Effective contraception if female in fertile age Exclusion Criteria: * Positive serology at screening * Pregnant or lactating * Other disease like Type 1 diabetes, cardiovascular disease, cancer, inflammatory bowel disease, thyroid or kidney disease * On immunosuppressive drugs * Smoking * Food allergy including wheat allergy * Acute infection
Where this trial is running
Mainz and 1 other locations
- Clinical Center for Celiac Disease and Autoimmunity — Mainz, Germany (Not_yet_recruiting)
- Dept of Gastroenterology — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Knut E A Lundin, PPhD, MD — Oslo University Hospital
- Study coordinator: Knut EA Lundin, PhD, MD
- Email: knut.lundin@medisin.uio.no
- Phone: +4790980325
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.