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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06151782
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Oslo University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Knut E A Lundin, PPhD, MD
Principal Investigator Affiliation	Oslo University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany, Norway
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease, Food Intolerance

Additional Details

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

Arms & Interventions

Arms

Active Comparator: Wheat gluten

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

Experimental: Barley gluten

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

Experimental: Low dose barley gluten

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

Experimental: Low dose hydrolyzed barley gluten

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Mainz, Germany

Status

Not yet recruiting

Address

Clinical Center for Celiac Disease and Autoimmunity

Mainz, , 55131

Site Contact

Detlef Schuppan, MD, PhD

detlef.schuppan@unimedizin-mainz.de

+4790980325

Dept of Gastroenterology, Oslo, Norway

Status

Recruiting

Address

Dept of Gastroenterology

Oslo, , 0881

Site Contact

Knut Erik A Lundin, MD, PhD

k.e.a.lundin@medisin.uio.no

90980325

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