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

NCT ID: NCT06151782

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-06-01

Brief 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.

Detailed Description

Celiac disease (CeD) is a common food-induced inflammatory disease of the small intestine caused by the ingestion of gluten from wheat, barley and rye. It is one of the most prevalent food hypersensitivities worldwide and affects 0.5-2.5% of the European population. The only effective treatment available is a strict lifelong gluten-free (GF) diet. GF products for CeD patients must not exceed the regulatory threshold of 20 mg/kg of gluten. Compliance of foods containing fermented or partially hydrolysed gluten is routinely assessed using the R5 competitive enzyme-linked immunosorbent assay (ELISA). However, this test does not adequately represent gluten immunogenicity in CeD patients. The overall objective of our ImmunoSafe-CeD proposal is to determine the CeD immunogenic activity of intact and partially hydrolysed gluten from wheat, rye and barley and develop improved comprehensive functional and analytical assays, including novel ELISAs and quantitative proteomics methods to ensure food safety for CeD patients. Thus, our objective is designed to directly address the needs of the CeD community about being reassured that GF products that contain partially hydrolysed gluten are safe and suitable for inclusion in their GF diet. By combining discovery proteomics and quantitative LC-MS/MS methods, improved reference materials for partially hydrolysed gluten, CeD-patient derived monoclonal antibodies and functional gluten-specific T-cell assays, we will provide a comprehensive and unique toolbox of novel and validated methods to detect gluten (both intact and partially hydrolysed) in foods for CeD patients.

This toolbox will close the current discrepancy between food analytical methods and CeD immunogenicity for the first time, because all methods will be matched to clinical pathophysiology assessed by food challenge in CeD patients. Our multidisciplinary consortium is built on previous highly successful collaborations and we are well-positioned to create even more synergies between us by exchanging materials, know-how and data. We expect to 1) better understand the role that the different glutens play in CeD pathogenesis, 2) develop easy-to-perform and reliable analytical tools (ELISA) that quantitate and predict immunogenicity (toxicity) of wheat, rye and barley products for CeD patients, and 3) define foods that CeD patients can tolerate despite being partly based on these processed grains

Conditions

Celiac Disease; Food Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Wheat gluten

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

Group Type: ACTIVE_COMPARATOR

Wheat gluten 1000 mg

Intervention Type: DIETARY_SUPPLEMENT

Nothing to add here

Barley gluten

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

Group Type: EXPERIMENTAL

Barley gluten 1000 mg

Intervention Type: DIETARY_SUPPLEMENT

Nothing to add here

Low dose barley gluten

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

Group Type: EXPERIMENTAL

Barley gluten 50 mg

Intervention Type: DIETARY_SUPPLEMENT

Nothing to add here

Low dose hydrolyzed barley gluten

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

Group Type: EXPERIMENTAL

Barley hydrolyzed gluten 50 mg

Intervention Type: DIETARY_SUPPLEMENT

Nothing to add here

Placebo slurry

Group Type: PLACEBO_COMPARATOR

Placebo slurry

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Wheat gluten 1000 mg

Nothing to add here

Intervention Type: DIETARY_SUPPLEMENT

Barley gluten 1000 mg

Nothing to add here

Intervention Type: DIETARY_SUPPLEMENT

Barley gluten 50 mg

Nothing to add here

Intervention Type: DIETARY_SUPPLEMENT

Barley hydrolyzed gluten 50 mg

Nothing to add here

Intervention Type: DIETARY_SUPPLEMENT

Placebo slurry

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Knut E. A. Lundin

Senior consultant, professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Knut E A Lundin, PPhD, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Clinical Center for Celiac Disease and Autoimmunity

Mainz, Germany, Germany

Dept of Gastroenterology

Oslo, Oslo County, Norway

Countries

Germany; Norway

Other Identifiers

2637128

Identifier Type: -

Identifier Source: org_study_id