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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gluten shake | Active Comparator | Liquid form |
|
| Gluten cookie | Active Comparator | Solid form |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vital wheat gluten | Dietary Supplement | Gluten-containing shake vs gluten-containing cookie |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 4 hours at visit 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between serum IL-2 response levels and baseline whole blood plasma IL-2 | From baseline to 6 hours after gluten intake | |
| Correlation between serum IL-2 response levels and baseline number of gluten-specific T cells | From baseline to 6 hours after gluten intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | Oslo | 0372 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33239013 | Background | 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. | |
| 31505020 | Background |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| D014202 | Tremor |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Vital wheat gluten | Dietary Supplement | Half of participants will receive gluten-containing shake first, then gluten-containing cookie next, and vice versa |
|
| Correlation between serum IL-2 response levels and symptom severity | From baseline to 6 hours after gluten intake |
| Comparison of serum IL-2 response levels and serum gluten peptide levels | From baseline to 6 hours after gluten intake |
| Lovisenberg Diakonale Hospital | Recruiting | Oslo | Oslo | 0456 | Norway |
|
| Goel 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. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |