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Immunosafe-CeD: Are Partially Hydrolysed Gluten Harmful to Celiac Disease Patients?

NCT06151782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-04-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Wheat gluten 1000 mg

Nothing to add here

DIETARY_SUPPLEMENT

Barley gluten 1000 mg

Nothing to add here

DIETARY_SUPPLEMENT

Barley gluten 50 mg

Nothing to add here

DIETARY_SUPPLEMENT

Barley hydrolyzed gluten 50 mg

Nothing to add here

DIETARY_SUPPLEMENT

Placebo slurry

In slurry, measurement of immune activation (Interleukin-2) four hours after intake

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Knut E A Lundin, PPhD, MD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-05-30
Completion
2025-06-01

Countries

  • Germany
  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06151782 on ClinicalTrials.gov