Celiac DiseaseNCT05209568
Immune Responses to Gluten
A study testing Gluten Powder in people with Celiac Disease and Malabsorption Syndromes, run by Boston Children's Hospital at 2 sites in United States.
Trial summary
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls. Read more about this study
- Who is it for?
- Ages 2 to 101 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease, Malabsorption Syndromes, Digestive System Disease
- What is being tested?
- Gluten Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2023to 30 Sep 2029
- 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 2 to 101 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- On a gluten-free diet for ≥ 4 weeks
- Willing to consume gluten for research
- For the celiac disease arm, diagnosis confirmed by serology and/or histology
Who cannot join
- Pregnancy
- Wheat allergy
- Type 1 diabetes
- BMI z-score < -2
- History of more than minimal symptoms following gluten exposure on a gluten-free diet
- Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.
Read the detailed description
This is a multi-site open-label single dose gluten challenge study. Participants will provide a blood sample for measurement of cytokines before and 4 hours after eating gluten powder.
- Conditions
- Celiac Disease, Malabsorption Syndromes, Digestive System Disease, Intestinal Disease, Gastrointestinal Diseases, Gluten Sensitivity
- Being tested
- Gluten Powder
- Keywords
- gluten, cytokine, T cell immune response
- Medical subject headings
- Celiac Disease, Malabsorption Syndromes, Digestive System Diseases, Intestinal Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten PowderDietary supplement
Single oral dose of gluten powder
| Study group | Role | What they receive |
|---|---|---|
| Celiac Disease | Experimental | Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology Receives: Dietary Supplement: Gluten Powder |
| Healthy Controls | Experimental | Individuals without a diagnosis of celiac disease Receives: Dietary Supplement: Gluten Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten
To determine the change in serum IL-2 level from baseline after a single oral dose of gluten
Measured: Baseline, 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start15 Jan 2023
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Boston Children's 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-center study of immune responses to gluten in persons with celiac disease and healthy controls. All participants will have baseline blood drawn to assess immune responses at baseline in addition to four hours after a single oral dose of gluten.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Principal investigator, Nan Du, Boston Children's Hospital
- Investigators
- Jocelyn A Silvester, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209568
- Sponsor's protocol ID
- P00039708
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant demographic and cytokine data collected during the trial, after deidentification.
Publications
Goel G, Tye-Din JA, Qiao SW, Russell AK, Mayassi T, Ciszewski C, Sarna VK, Wang S, Goldstein KE, Dzuris JL, Williams LJ, Xavier RJ, Lundin KEA, Jabri B, Sollid LM, Anderson RP. Cytokine release and gastrointestinal symptoms after gluten challenge in celiac disease. Sci Adv. 2019 Aug 7;5(8):eaaw7756. doi: 10.1126/sciadv.aaw7756. eCollection 2019 Aug.
PubMed 31457091Goel 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 31505020Tye-Din JA, Daveson AJM, Ee HC, Goel G, MacDougall J, Acaster S, Goldstein KE, Dzuris JL, Neff KM, Truitt KE, Anderson RP. Elevated serum interleukin-2 after gluten correlates with symptoms and is a potential diagnostic biomarker for coeliac disease. Aliment Pharmacol Ther. 2019 Oct;50(8):901-910. doi: 10.1111/apt.15477. Epub 2019 Sep 4.
PubMed 31483515
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten
- ClinicalTrials.gov ID
- NCT05209568
- Acronym / sponsor ID
- P00039708
- Conditions
- Celiac Disease, Malabsorption Syndromes, Digestive System Disease, Intestinal Disease, Gastrointestinal Diseases, Gluten Sensitivity
- Keywords
- gluten, cytokine, T cell immune response
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 26 Jan 2022 (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.
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.
Detailed description
This is a multi-site open-label single dose gluten challenge study. Participants will provide a blood sample for measurement of cytokines before and 4 hours after eating gluten powder.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multi-center study of immune responses to gluten in persons with celiac disease and healthy controls. All participants will have baseline blood drawn to assess immune responses at baseline in addition to four hours after a single oral dose of gluten.
| Arm | Type | Receives |
|---|---|---|
| Celiac Disease | Experimental | Dietary Supplement: Gluten PowderIndividuals with a confirmed diagnosis of celiac disease based on serology and/or histology |
| Healthy Controls | Experimental | Dietary Supplement: Gluten PowderIndividuals without a diagnosis of celiac disease |
Who may qualify
- Ages
- 2 to 101 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- On a gluten-free diet for ≥ 4 weeks
- Willing to consume gluten for research
- For the celiac disease arm, diagnosis confirmed by serology and/or histology
Key exclusion criteria (6 listed)
- Pregnancy
- Wheat allergy
- Type 1 diabetes
- BMI z-score < -2
- History of more than minimal symptoms following gluten exposure on a gluten-free diet
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 |
|---|---|---|
| Gluten PowderSingle oral dose of gluten powder | Dietary supplement | Celiac Disease, Healthy Controls |
Primary outcome
Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten
Time frame: Baseline, 4 hours
To determine the change in serum IL-2 level from baseline after a single oral dose of gluten
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 11 Sep 2026.
- Background: PubMed 31457091Goel G, Tye-Din JA, Qiao SW, Russell AK, Mayassi T, Ciszewski C, Sarna VK, Wang S, Goldstein KE, Dzuris JL, Williams LJ, Xavier RJ, Lundin KEA, Jabri B, Sollid LM, Anderson RP. Cytokine release and gastrointestinal symptoms after gluten challenge in celiac disease. Sci Adv. 2019 Aug 7;5(8):eaaw7756. doi: 10.1126/sciadv.aaw7756. eCollection 2019 Aug.
- 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.
- Background: PubMed 31483515Tye-Din JA, Daveson AJM, Ee HC, Goel G, MacDougall J, Acaster S, Goldstein KE, Dzuris JL, Neff KM, Truitt KE, Anderson RP. Elevated serum interleukin-2 after gluten correlates with symptoms and is a potential diagnostic biomarker for coeliac disease. Aliment Pharmacol Ther. 2019 Oct;50(8):901-910. doi: 10.1111/apt.15477. Epub 2019 Sep 4.
- Individual participant dataSharing planned: Yes. Individual participant demographic and cytokine data collected during the trial, after deidentification.
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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.
Jocelyn A Silvester, MD, PhD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten Powder in people with Celiac Disease and Malabsorption Syndromes, run by Boston Children's Hospital at 2 sites in United States.
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 3 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 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 United States. 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?
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?
Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten (time frame: Baseline, 4 hours). 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 NCT05209568, which also lists 3 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 11 Sep 2026.