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NCT06151782
Immunosafe-CeD: Are Partially Hydrolysed Gluten Harmful to Celiac Disease Patients?
NA trial testing Wheat gluten 1000 mg in Celiac Disease in 33 participants. Completed in 1 June 2025.
30 May 2025
Quick facts
| Lead sponsor | Oslo University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 33 |
| Start date | 1 January 2024 |
| Primary completion | 30 May 2025 |
| Estimated completion | 1 June 2025 |
| Sites | 2 locations across Germany, Norway |
Drugs / interventions tested
- Wheat gluten 1000 mg
- Barley gluten 1000 mg
- Barley gluten 50 mg
- Barley hydrolyzed gluten 50 mg
- Placebo slurry — full drug profile →
Conditions studied
- Celiac Disease — all drugs for Celiac Disease →
- Food Intolerance — all drugs for Food Intolerance →
Sponsor
Oslo University Hospital
Who can join
18 and older, any sex, with Celiac Disease or Food Intolerance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study will compare the immune response in CeD patients to wheat and barley gluten at high doses (1 gram), and also investigate the reponses to low dose barley gluten and also hydrolyzed, malted barley and placebo. This will be done by five one-day challenges with intervals around four weeks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06151782
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06151782 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Oslo University Hospital
- Last refreshed: 29 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06151782.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing