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

Sponsor

Oslo University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06151782

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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. This will be done by four one-day challenges with intervals around four weeks.

Condition or Disease	Intervention/Treatment	Phase
Celiac Disease Food Intolerance	Dietary Supplement: Wheat gluten 1000 mg Dietary Supplement: Barley gluten 1000 mg Dietary Supplement: Barley gluten 50 mg Dietary Supplement: Barley hydrolyzed gluten 50 mg	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Participants will be challenged by single bolus four times four weeks apart.Participants will be challenged by single bolus four times four weeks apart.

Masking:

Single (Investigator)

Primary Purpose:

Diagnostic

Official Title:

Towards Comprehensive Analytical Methods for Partially Hydrolysed Gluten to Assess Product Safety for Celiac Disease Patients

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Wheat gluten In slurry, measurement of immune activation (Interleukin-2) four hours after intake	Dietary Supplement: Wheat gluten 1000 mg Nothing to add here
Experimental: Barley gluten In slurry, measurement of immune activation (Interleukin-2) four hours after intake	Dietary Supplement: Barley gluten 1000 mg Nothing to add here
Experimental: Low dose barley gluten In slurry, measurement of immune activation (Interleukin-2) four hours after intake	Dietary Supplement: Barley gluten 50 mg Nothing to add here
Experimental: Low dose hydrolyzed barley gluten In slurry, measurement of immune activation (Interleukin-2) four hours after intake	Dietary Supplement: Barley hydrolyzed gluten 50 mg Nothing to add here

Outcome Measures

Primary Outcome Measures

Interleukin-2 in serum [4 hours after intake]
Cytokine measurement by MSD Mesoscale

Secondary Outcome Measures

GIP in urine 4 hours after challenge and feces 2 days after challenge [Four hours after challenge (urine) and 2 days after challenge (feces)]
Detection of gluten by test kits for BioMedal

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept of Gastroenterology	Oslo		Norway	0881

Sponsors and Collaborators

Oslo University Hospital

Investigators

Principal Investigator: Knut E A Lundin, PPhD, MD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Knut E. A. Lundin, Senior consultant, professor, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT06151782

Other Study ID Numbers:

2637128

First Posted:

Nov 30, 2023

Last Update Posted:

Nov 30, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Celiac Disease

Food Intolerance

Study Results

No Results Posted as of Nov 30, 2023