Celiac DiseaseSHAKENCT07039773
Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?
A study testing Vital wheat gluten in people with Celiac Disease, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The goal of this clinical trial is to evaluate the immune response to gluten in patients with celiac disease (CeD) by comparing different forms of gluten administration. The participant population includes adults diagnosed with CeD, who are adhering to a gluten-free diet (GFD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Vital wheat gluten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Aug 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 18-33 kg/m2
- Willingness to comply with the study procedure and having signed informed, written consent
- Previous diagnosis of coeliac disease according to established guidelines based on positive serology (Endomysium test, IgA-TG2 and/or IgG-DGP) (diagnosed in childhood) and a duodenal biopsy showing villous atrophy graded as Marsh 3 according to guidelines from European Society for Study of Coeliac Disease .
- Strict adherence to a gluten-free diet at least the 12 last months.
Who cannot join
- Positive serology (IgA-TG2 below upper level of normal) at screening visit
- Pregnancy or breast feeding. Fertile women must use effective contraception.
- Other inflammatory disease like uncontrolled hypothyreosis, type 1 diabetes, cardiovascular diseases, thyroid and renal disorders, inflammatory bowel diseases or any other disease that in the opinion of the responsible clinician makes the patient unsuitable for the study
- Using of immunosuppressive/steroid medications
- Wheat allergy
- Severe acute infection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Oslo University Hospital
Oslo, Oslo, 0372
Stine R Lund, +47 230 72 403, coliaki@ous-hf.no
Knut E A Lundin, MD, PhD
- Recruiting
Lovisenberg Diakonale Hospital
Oslo, Oslo, 0456
Anita Tollisen, PhD, +4723225140, coliaki@ous-hf.no
Jørgen Valeur, MD, PhD
About this study
Official title: Assessing Immune Responses to Gluten: A Comparative Study of Liquid Versus Solid Gluten Administration
The goal of this clinical trial is to evaluate the immune response to gluten in patients with celiac disease (CeD) by comparing different forms of gluten administration. The participant population includes adults diagnosed with CeD, who are adhering to a gluten-free diet (GFD). The main questions it aims to answer are:
- Does liquid gluten administration elicit a higher IL-2 cytokine response compared to solid gluten administration?
- What is the relationship between serum IL-2 levels and gluten peptide serum concentrations following gluten challenges?
Read more
Researchers will compare the responses of two groups: participants receiving liquid gluten (shake) to those receiving solid gluten (cookie) to determine if there is a significant difference in the IL-2 response rates between the two forms.
Participants will be asked to:
- Undergo two gluten challenges (liquid and solid) in a randomized order with at least 4 weeks apart.
- Provide blood samples before and after each challenge to measure serum IL-2 levels and gluten peptide concentrations over a period of 6 hours.
- Report any symptoms experienced following each gluten challenge.
- Conditions
- Celiac Disease
- Being tested
- Vital wheat gluten
- Keywords
- Gluten challenge, Interleukin-2, Shake, Cookie, T cells, Whole blood cytokine release assay, GI Symptoms
- Medical subject headings
- Celiac Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital wheat glutenDietary supplement
Gluten-containing shake vs gluten-containing cookie
Vital wheat glutenDietary supplement
Half of participants will receive gluten-containing shake first, then gluten-containing cookie next, and vice versa
| Study group | Role | What they receive |
|---|---|---|
| Gluten shake | Active comparator | Liquid form Receives: Dietary Supplement: Vital wheat gluten |
| Gluten cookie | Active comparator | Solid form Receives: Dietary Supplement: Vital wheat gluten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of serum IL-2 response rates between the gluten shake group and the cookie group
A responder is defined as an individual exhibiting a log-transformed cytokine level equal to or greater than 0. This level corresponds to 1.0 pg/ml in concentration of IL-2 in serum. The hypothesis is that there is a higher proportion of responders in the gluten shake group compared to the cookie group.
Measured: From baseline to 4 hours at visit 1
Secondary outcomes (4)
Correlation between serum IL-2 response levels and baseline whole blood plasma IL-2
Measured: From baseline to 6 hours after gluten intake
Correlation between serum IL-2 response levels and baseline number of gluten-specific T cells
Measured: From baseline to 6 hours after gluten intake
Correlation between serum IL-2 response levels and symptom severity
Measured: From baseline to 6 hours after gluten intake
Comparison of serum IL-2 response levels and serum gluten peptide levels
Measured: From baseline to 6 hours after gluten intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039773
- Sponsor's protocol ID
- 24/27476
- Acronym
- SHAKE
- Status last verified
- Apr 2026
- First submitted
- 18 Jun 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tye-Din JA, Daveson AJM, Goldstein KE, Hand HL, Neff KM, Goel G, Williams LJ, Truitt KE, Anderson RP; RESET CeD Study Group. Patient factors influencing acute gluten reactions and cytokine release in treated coeliac disease. BMC Med. 2020 Nov 26;18(1):362. doi: 10.1186/s12916-020-01828-y.
PubMed 33239013Goel G, Daveson AJM, Hooi CE, Tye-Din JA, Wang S, Szymczak E, Williams LJ, Dzuris JL, Neff KM, Truitt KE, Anderson RP. Serum cytokines elevated during gluten-mediated cytokine release in coeliac disease. Clin Exp Immunol. 2020 Jan;199(1):68-78. doi: 10.1111/cei.13369. Epub 2019 Oct 1.
PubMed 31505020
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Immune Responses to Gluten: A Comparative Study of Liquid Versus Solid Gluten Administration
- ClinicalTrials.gov ID
- NCT07039773
- Acronym / sponsor ID
- SHAKE / 24/27476
- Conditions
- Celiac Disease
- Keywords
- Gluten challenge, Interleukin-2, Shake, Cookie, T cells, Whole blood cytokine release assay, GI Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jun 2025 (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 goal of this clinical trial is to evaluate the immune response to gluten in patients with celiac disease (CeD) by comparing different forms of gluten administration. The participant population includes adults diagnosed with CeD, who are adhering to a gluten-free diet (GFD). The main questions it aims to answer are:
- Does liquid gluten administration elicit a higher IL-2 cytokine response compared to solid gluten administration?
- What is the relationship between serum IL-2 levels and gluten peptide serum concentrations following gluten challenges?
Researchers will compare the responses of two groups: participants receiving liquid gluten (shake) to those receiving solid gluten (cookie) to determine if there is a significant difference in the IL-2 response rates between the two forms.
Participants will be asked to:
- Undergo two gluten challenges (liquid and solid) in a randomized order with at least 4 weeks apart.
- Provide blood samples before and after each challenge to measure serum IL-2 levels and gluten peptide concentrations over a period of 6 hours.
- Report any symptoms experienced following each gluten challenge.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gluten shake | Active comparator | Dietary Supplement: Vital wheat glutenLiquid form |
| Gluten cookie | Active comparator | Dietary Supplement: Vital wheat glutenSolid form |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI 18-33 kg/m2
- Willingness to comply with the study procedure and having signed informed, written consent
- Previous diagnosis of coeliac disease according to established guidelines based on positive serology (Endomysium test, IgA-TG2 and/or IgG-DGP) (diagnosed in childhood) and a duodenal biopsy showing villous atrophy graded as Marsh 3 according to guidelines from European Society for Study of Coeliac Disease .
- Strict adherence to a gluten-free diet at least the 12 last months.
Key exclusion criteria (6 listed)
- Positive serology (IgA-TG2 below upper level of normal) at screening visit
- Pregnancy or breast feeding. Fertile women must use effective contraception.
- Other inflammatory disease like uncontrolled hypothyreosis, type 1 diabetes, cardiovascular diseases, thyroid and renal disorders, inflammatory bowel diseases or any other disease that in the opinion of the responsible clinician makes the patient unsuitable for the study
- Using of immunosuppressive/steroid medications
- Wheat allergy
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 |
|---|---|---|
| Vital wheat glutenGluten-containing shake vs gluten-containing cookie | Dietary supplement | Gluten cookie, Gluten shake |
| Vital wheat glutenHalf of participants will receive gluten-containing shake first, then gluten-containing cookie next, and vice versa | Dietary supplement | Gluten cookie, Gluten shake |
Primary outcome
Comparison of serum IL-2 response rates between the gluten shake group and the cookie group
Time frame: From baseline to 4 hours at visit 1
A responder is defined as an individual exhibiting a log-transformed cytokine level equal to or greater than 0. This level corresponds to 1.0 pg/ml in concentration of IL-2 in serum. The hypothesis is that there is a higher proportion of responders in the gluten shake group compared to the cookie group.
4 secondary outcomes
Correlation between serum IL-2 response levels and baseline whole blood plasma IL-2
Time frame: From baseline to 6 hours after gluten intake
Correlation between serum IL-2 response levels and baseline number of gluten-specific T cells
Time frame: From baseline to 6 hours after gluten intake
Correlation between serum IL-2 response levels and symptom severity
Time frame: From baseline to 6 hours after gluten intake
Comparison of serum IL-2 response levels and serum gluten peptide levels
Time frame: From baseline to 6 hours after gluten intake
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 33239013Tye-Din JA, Daveson AJM, Goldstein KE, Hand HL, Neff KM, Goel G, Williams LJ, Truitt KE, Anderson RP; RESET CeD Study Group. Patient factors influencing acute gluten reactions and cytokine release in treated coeliac disease. BMC Med. 2020 Nov 26;18(1):362. doi: 10.1186/s12916-020-01828-y.
- Background: PubMed 31505020Goel G, Daveson AJM, Hooi CE, Tye-Din JA, Wang S, Szymczak E, Williams LJ, Dzuris JL, Neff KM, Truitt KE, Anderson RP. Serum cytokines elevated during gluten-mediated cytokine release in coeliac disease. Clin Exp Immunol. 2020 Jan;199(1):68-78. doi: 10.1111/cei.13369. Epub 2019 Oct 1.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vital wheat gluten in people with Celiac Disease, run by Oslo University Hospital at 2 sites in Norway.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 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 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of serum IL-2 response rates between the gluten shake group and the cookie group (time frame: From baseline to 4 hours at visit 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07039773, which also lists 2 linked publications.
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 17 Apr 2026.