Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06151782
Other study ID # 2637128
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2026

Study information

Verified date December 2023
Source Oslo University Hospital
Contact Knut EA Lundin, PhD, MD
Phone +4790980325
Email knut.lundin@medisin.uio.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 31, 2026
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Wheat gluten 1000 mg
Nothing to add here
Barley gluten 1000 mg
Nothing to add here
Barley gluten 50 mg
Nothing to add here
Barley hydrolyzed gluten 50 mg
Nothing to add here

Locations

Country Name City State
Germany Clinical Center for Celiac Disease and Autoimmunity Mainz
Norway Dept of Gastroenterology Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Countries where clinical trial is conducted

Germany,  Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Interleukin-2 in serum Cytokine measurement by MSD Mesoscale 4 hours after intake
Secondary GIP in urine 4 hours after challenge and feces 2 days after challenge Detection of gluten by test kits for BioMedal Four hours after challenge (urine) and 2 days after challenge (feces)
See also
  Status Clinical Trial Phase
Completed NCT04349904 - Near-Focus NBI Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Completed NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Completed NCT05810441 - Intestinal Transglutaminase Antibodies in Celiac Disease Diagnosis
Recruiting NCT05555446 - Bovine Colostrum to Prevent Absorption of Gluten Early Phase 1
Completed NCT02754609 - Hookworm Therapy for Coeliac Disease Phase 1
Terminated NCT01902368 - Celiac Disease Screening N/A
Completed NCT02312349 - Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
Completed NCT02472704 - Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo N/A
Completed NCT01172665 - Celiac Disease Database
Completed NCT01100099 - HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease Phase 2/Phase 3
Completed NCT00639444 - Risk of Celiac Disease and Age at Gluten Introduction N/A
Active, not recruiting NCT05425446 - Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients Phase 1
Enrolling by invitation NCT02202681 - Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule N/A
Completed NCT00362856 - Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects Phase 2
Terminated NCT03866538 - Budesonide in Patients With Immune Mediated Enteropathies Phase 4
Recruiting NCT05135923 - Glutenfree, Gut Microbiota and Metabolic Regulation N/A
Completed NCT05052164 - Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women N/A
Completed NCT03775499 - Probiotic BL NCC 2705 and Gluten Sensitivity N/A
Completed NCT03707730 - A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease Phase 2