Testing gluten effects in people with celiac disease
Gluten Challenge in Celiac Disease
This study is testing how eating gluten for a few days affects the immune response in people with celiac disease who have been on a gluten-free diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT02464150 on ClinicalTrials.gov |
What this trial studies
This study involves up to 30 participants with celiac disease who have been on a gluten-free diet for at least six months. Participants will consume gluten-containing cookies or bread for three days, after which blood samples will be collected before and six days after the gluten challenge. The study aims to analyze gluten-specific T cells using HLA-tetramers and flow cytometry, providing insights into the immune response to gluten. Additional analyses will include other T cell populations to understand the broader immune response.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a confirmed diagnosis of celiac disease who have adhered to a gluten-free diet for the past six months.
Not a fit: Patients who are pregnant, breastfeeding, or have serious reactions to gluten may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the immune mechanisms in celiac disease and lead to improved management strategies.
How similar studies have performed: Similar studies have explored immune responses in celiac disease, but this specific approach to analyzing gluten-specific T cells is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Celiac disease confirmed by biopsy * Age 18 - 80 years * Gluten free diet last 6 months * Subject has received information and signed the informed consent form Exclusion Criteria: * Pregnant or breast feeding * Probability of participant becoming pregnant (f.ex. by not using adequate sexual prevention by woman in fertile age) * Drugs influencing immune system used last 3 months * Current infectious disease of moderate or high severity * Other chronic active intestinal disease * Serious reaction on small amounts of gluten ingested
Where this trial is running
Oslo
- Oslo university hospital - Rikshospitalet — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Knut EA Lundin, MD PhD — Oslo University Hospital and University of Oslo
- Study coordinator: Stephanie Zühlke, MD
- Email: stephanie.zuhlke@medisin.uio.no
- Phone: 23074224
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.