Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-04 @ 5:07 PM
Study NCT ID:
NCT02690532
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2016-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Permeability Assessment in Celiac and Gluten Sensitive Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2016-02-19', 'studyFirstSubmitQcDate': '2016-02-19', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut Permeability', 'timeFrame': 'Baseline', 'description': 'Assess the effect of gluten on gut permeability in children at high risk of developing celiac disease or gluten sensitivity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Celiac', 'Gluten', 'Sensitivity', 'Permeability', 'Non-celiac gluten intolerance', 'Gastrointestinal Diseases', 'Digestive System Diseases'], 'conditions': ['Celiac Disease']}, 'descriptionModule': {'briefSummary': 'This study will assess the effect of gluten on gut barrier function. Investigators at the Mayo Clinic have developed a new gut permeability test using rhamnose (sugar \\& water solution), and are hoping to prove its effectiveness in a clinical setting.', 'detailedDescription': 'The aim of this study is to assess effect of gluten on the gut barrier function in patients at high risk for celiac disease and non-celiac gluten sensitivity (NCGS) patients. This study will assess the gut permeability in three groups of patients 1) children who are at high risk for developing celiac disease (CD) (siblings of patients with celiac disease), 2) Children who are self-diagnosed with NCGS and 3) control group of patients matched for age and gender. Patients will undergo celiac serologic and genetic testing, after which the rhamnose test will be performed to assess the presence of increased gut permeability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of three groups of children, aged 2-17 years. The first group will be children with siblings that have celiac disease, the second group will be children with non-celiac gluten sensitivity and the third group will be healthy children.', 'healthyVolunteers': True, 'eligibilityCriteria': 'High Risk group:\n\n* Sibling with a confirmed diagnosis of celiac disease\n* No history Celiac disease or any other bowel disease\n\nNon-Celiac Gluten Sensitivity group:\n\n* Self-diagnosis of gluten sensitivity\n* No history of celiac disease or other bowel disease\n\nHealthy group:\n\n* Absence of celiac disease or any other bowel disease\n* No sensitivity to gluten'}, 'identificationModule': {'nctId': 'NCT02690532', 'briefTitle': 'Gut Permeability Assessment in Celiac and Gluten Sensitive Children', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Role of Gut Permeability in Developing Celiac Disease and Non-Celiac Gluten Sensitivity', 'orgStudyIdInfo': {'id': '15-006018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High risk group', 'description': 'Children who are at high risk for developing celiac disease (siblings diagnosed with celiac disease).'}, {'label': 'Non-celiac group', 'description': 'Children who are self-diagnosed with non-celiac gluten sensitivity.'}, {'label': 'Control Group', 'description': 'Healthy control group (matched for age and gender).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Imad Absah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Assistant Professor of Pediatrics', 'investigatorFullName': 'Imad Absah', 'investigatorAffiliation': 'Mayo Clinic'}}}}