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

NCT06151782 | Completed

• 1 other identifier: 2637128
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 2

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.

Conditions

Celiac Disease; Food Intolerance

Outcome Measures

Primary Outcomes (1)

• Interleukin-2 in serum

  Cytokine measurement by MSD Mesoscale

  4 hours after intake

Secondary Outcomes (3)

• GIP in urine 4 hours after challenge and feces 2 days after challenge

  Four hours after challenge (urine) and 2 days after challenge (feces)

• Immune reaction to wheat and barley

  Before each patient has been challenged

• PROM

  At baseline and at each of the five challenges; at time 0, 1hour, 2hours, 3hours and 4hours after the challenge. We use a VAS score and the GSRS form.

Study Arms (5)

Wheat gluten

ACTIVE COMPARATOR

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

Dietary Supplement: Wheat gluten 1000 mg

Barley gluten

EXPERIMENTAL

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

Dietary Supplement: Barley gluten 1000 mg

Low dose barley gluten

EXPERIMENTAL

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

Dietary Supplement: Barley gluten 50 mg

Low dose hydrolyzed barley gluten

EXPERIMENTAL

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

Dietary Supplement: Barley hydrolyzed gluten 50 mg

Placebo slurry

PLACEBO COMPARATOR

Dietary Supplement: Placebo slurry

Interventions

Wheat gluten 1000 mg DIETARY_SUPPLEMENT

Nothing to add here

Wheat gluten

Barley gluten 1000 mg DIETARY_SUPPLEMENT

Nothing to add here

Barley gluten

Barley gluten 50 mg DIETARY_SUPPLEMENT

Nothing to add here

Low dose barley gluten

Barley hydrolyzed gluten 50 mg DIETARY_SUPPLEMENT

Nothing to add here

Low dose hydrolyzed barley gluten

Placebo slurry DIETARY_SUPPLEMENT

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

Placebo slurry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (2)

Clinical Center for Celiac Disease and Autoimmunity

Mainz, Germany, 55131, Germany

Location

Dept of Gastroenterology

Oslo, Oslo, 0881, Norway

Location

MeSH Terms

Conditions

Celiac Disease; Food Intolerance

Interventions

Glutens

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Officials

• Knut E A Lundin, PPhD, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant, professor

Model Details: Participants will be challenged by single bolus five times four weeks apart.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 30, 2023
• Study Start: January 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 1, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

NO (1); DE (1)