Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-02-19 @ 5:09 AM
Study NCT ID:
NCT04148235
Status:
WITHDRAWN
Last Update Posted:
2025-06-05
First Post:
2019-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Explore the Role of Gut Flora in Celiac Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool Samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Company focus shifted', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Microbiome to Celiac Disease via Relative Abundance Found in Microbiome Sequencing', 'timeFrame': 'One year', 'description': 'Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific disease types.'}], 'secondaryOutcomes': [{'measure': 'Validation of Sequencing Methods', 'timeFrame': 'One year', 'description': 'To validate the methods used to sequence samples'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Celiac Disease']}, 'descriptionModule': {'briefSummary': 'This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Celiac Disease.', 'detailedDescription': "The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Celiac Disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with Celiac Disease', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study\n2. Male or female patients of any age (interest is given to children to compare with mothers).\n3. Diagnosis of Celiac Disease\n\nExclusion Criteria:\n\n1. Refusal to sign informed consent form\n2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.\n3. Postoperative stoma, ostomy, or ileoanal pouch\n4. Participation in any experimental drug protocol within the past 12 weeks\n5. Treatment with total parenteral nutrition\n6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial\n7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study"}, 'identificationModule': {'nctId': 'NCT04148235', 'briefTitle': 'A Pilot Study to Explore the Role of Gut Flora in Celiac Disease', 'organization': {'class': 'OTHER', 'fullName': 'ProgenaBiome'}, 'officialTitle': 'A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Celiac Disease', 'orgStudyIdInfo': {'id': 'PRG-020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients who have been diagnosed with Celiac Disease', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'There is no intervention for this study', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'ProgenaBiome', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}], 'overallOfficials': [{'name': 'Sabine Hazan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ProgenaBiome'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProgenaBiome', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}