Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
Study NCT ID:
NCT05209568
Status:
RECRUITING
Last Update Posted:
2025-04-23
First Post:
2022-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Responses to Gluten
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten', 'timeFrame': 'Baseline, 4 hours', 'description': 'To determine the change in serum IL-2 level from baseline after a single oral dose of gluten'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gluten', 'cytokine', 'T cell immune response'], 'conditions': ['Celiac Disease', 'Malabsorption Syndromes', 'Digestive System Disease', 'Intestinal Disease', 'Gastrointestinal Diseases', 'Gluten Sensitivity', 'Celiac Disease in Children']}, 'referencesModule': {'references': [{'pmid': '31457091', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31505020', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31483515', 'type': 'BACKGROUND', 'citation': 'Tye-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.'}]}, 'descriptionModule': {'briefSummary': 'This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '101 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. On a gluten-free diet for ≥ 4 weeks\n2. Willing to consume gluten for research\n3. For the celiac disease arm, diagnosis confirmed by serology and/or histology\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Wheat allergy\n3. Type 1 diabetes\n4. BMI z-score \\< -2\n5. History of more than minimal symptoms following gluten exposure on a gluten-free diet\n6. Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results'}, 'identificationModule': {'nctId': 'NCT05209568', 'briefTitle': 'Immune Responses to Gluten', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten', 'orgStudyIdInfo': {'id': 'P00039708'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Celiac Disease', 'description': 'Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology', 'interventionNames': ['Dietary Supplement: Gluten Powder']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Controls', 'description': 'Individuals without a diagnosis of celiac disease', 'interventionNames': ['Dietary Supplement: Gluten Powder']}], 'interventions': [{'name': 'Gluten Powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single oral dose of gluten powder', 'armGroupLabels': ['Celiac Disease', 'Healthy Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marisa Stahl, MD, MSCS', 'role': 'CONTACT', 'email': 'marisa.stahl@childrenscolorado.org', 'phone': '720-777-2484'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jocelyn A Silvester, MD, PhD', 'role': 'CONTACT', 'email': 'jocelyn.silvester@childrens.harvard.edu', 'phone': '617-355-8880'}], 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Jocelyn A Silvester, MD, PhD', 'role': 'CONTACT', 'email': 'jocelyn.silvester@childrens.harvard.edu', 'phone': '617-355-8880'}, {'name': 'Marisa Stahl, MD, MSCS', 'role': 'CONTACT', 'email': 'marisa.stahl@childrenscolorado.org'}], 'overallOfficials': [{'name': 'Jocelyn A Silvester, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant demographic and cytokine data collected during the trial, after deidentification.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital Colorado", 'class': 'OTHER'}, {'name': 'Celiac Disease Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research, Celiac Disease Program', 'investigatorFullName': 'Jocelyn Silvester', 'investigatorAffiliation': "Boston Children's Hospital"}}}}