Celiac DiseaseNCT06151782
Immunosafe-CeD: Are Partially Hydrolysed Gluten Harmful to Celiac Disease Patients?
A study testing Wheat gluten 1000 mg, Barley gluten 1000 mg and Barley gluten 50 mg in people with Celiac Disease and Food Intolerance, run by Oslo University Hospital at 2 sites in 2 countries.
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 and placebo. This will be done by five one-day challenges with intervals around four weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease, Food Intolerance
- What is being tested?
- Wheat gluten 1000 mg, Barley gluten 1000 mg and Barley gluten 50 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Clinical Center for Celiac Disease and Autoimmunity
Mainz, Germany, 55131
About this study
Official title: Towards Comprehensive Analytical Methods for Partially Hydrolysed Gluten to Assess Product Safety for Celiac Disease Patients
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.
Read the 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
- Being tested
- Wheat gluten 1000 mg, Barley gluten 1000 mg, Barley gluten 50 mg, Barley hydrolyzed gluten 50 mg, Placebo slurry
- Medical subject headings
- Celiac Disease, Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat gluten 1000 mgDietary supplement
Nothing to add here
Barley gluten 1000 mgDietary supplement
Nothing to add here
Barley gluten 50 mgDietary supplement
Nothing to add here
Barley hydrolyzed gluten 50 mgDietary supplement
Nothing to add here
Placebo slurryDietary supplement
In slurry, measurement of immune activation (Interleukin-2) four hours after intake
| Study group | Role | What they receive |
|---|---|---|
| Wheat gluten | Active comparator | In slurry, measurement of immune activation (Interleukin-2) four hours after intake Receives: Dietary Supplement: Wheat gluten 1000 mg |
| Barley gluten | Experimental | In slurry, measurement of immune activation (Interleukin-2) four hours after intake Receives: Dietary Supplement: Barley gluten 1000 mg |
| Low dose barley gluten | Experimental | In slurry, measurement of immune activation (Interleukin-2) four hours after intake Receives: Dietary Supplement: Barley gluten 50 mg |
| Low dose hydrolyzed barley gluten | Experimental | In slurry, measurement of immune activation (Interleukin-2) four hours after intake Receives: Dietary Supplement: Barley hydrolyzed gluten 50 mg |
| Placebo slurry | Placebo comparator | Not described Receives: Dietary Supplement: Placebo slurry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-2 in serum
Cytokine measurement by MSD Mesoscale
Measured: 4 hours after intake
Secondary outcomes (3)
GIP in urine 4 hours after challenge and feces 2 days after challenge
Detection of gluten by test kits for BioMedal
Measured: Four hours after challenge (urine) and 2 days after challenge (feces)
Immune reaction to wheat and barley
Whole-blood cytokine release assay where blood is challenged with gluten peptides
Measured: Before each patient has been challenged
PROM
Gastrointestinal symptom score after challenge assessed scoring forms
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Jan 2024
- Primary completion30 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be challenged by single bolus five times four weeks apart.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Knut E. A. Lundin, Oslo University Hospital
- Investigators
- Knut E A Lundin, PPhD, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151782
- Sponsor's protocol ID
- 2637128
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Comprehensive Analytical Methods for Partially Hydrolysed Gluten to Assess Product Safety for Celiac Disease Patients
- ClinicalTrials.gov ID
- NCT06151782
- Acronym / sponsor ID
- 2637128
- Conditions
- Celiac Disease, Food Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
- Model description
- Participants will be challenged by single bolus five times four weeks apart.
| Arm | Type | Receives |
|---|---|---|
| Wheat gluten | Active comparator | Dietary Supplement: Wheat gluten 1000 mgIn slurry, measurement of immune activation (Interleukin-2) four hours after intake |
| Barley gluten | Experimental | Dietary Supplement: Barley gluten 1000 mgIn slurry, measurement of immune activation (Interleukin-2) four hours after intake |
| Low dose barley gluten | Experimental | Dietary Supplement: Barley gluten 50 mgIn slurry, measurement of immune activation (Interleukin-2) four hours after intake |
| Low dose hydrolyzed barley gluten | Experimental | Dietary Supplement: Barley hydrolyzed gluten 50 mgIn slurry, measurement of immune activation (Interleukin-2) four hours after intake |
| Placebo slurry | Placebo comparator | Dietary Supplement: Placebo slurry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheat gluten 1000 mgNothing to add here | Dietary supplement | Wheat gluten |
| Barley gluten 1000 mgNothing to add here | Dietary supplement | Barley gluten |
| Barley gluten 50 mgNothing to add here | Dietary supplement | Low dose barley gluten |
| Barley hydrolyzed gluten 50 mgNothing to add here | Dietary supplement | Low dose hydrolyzed barley gluten |
| Placebo slurryIn slurry, measurement of immune activation (Interleukin-2) four hours after intake | Dietary supplement | Placebo slurry |
Primary outcome
Interleukin-2 in serum
Time frame: 4 hours after intake
Cytokine measurement by MSD Mesoscale
3 secondary outcomes
GIP in urine 4 hours after challenge and feces 2 days after challenge
Time frame: Four hours after challenge (urine) and 2 days after challenge (feces)
Immune reaction to wheat and barley
Time frame: Before each patient has been challenged
PROM
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut E A Lundin, PPhD, MD principal investigator
Oslo University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat gluten 1000 mg, Barley gluten 1000 mg and Barley gluten 50 mg in people with Celiac Disease and Food Intolerance, run by Oslo University Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-2 in serum (time frame: 4 hours after intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.