Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-02 @ 4:17 PM
Study NCT ID:
NCT04213651
Status:
WITHDRAWN
Last Update Posted:
2025-06-05
First Post:
2019-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Company shifted focus', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06',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': '2019-12-23', 'studyFirstSubmitQcDate': '2019-12-27', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing', 'timeFrame': 'Three years', '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 with diabetes mellitus'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.', 'detailedDescription': "The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to diabetes mellitus"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diabetes mellitus', '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\n\n a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent\n2. Male or female of all ages\n3. Diagnosis of diabetes mellitus based on blood glucose and/or hemoglobin A1C\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'}, 'identificationModule': {'nctId': 'NCT04213651', 'briefTitle': 'A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'ProgenaBiome'}, 'officialTitle': 'A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PRG-032'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes Mellitus', 'description': 'Patients with diabetes mellitus', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'There is no intervention for this study', 'armGroupLabels': ['Diabetes Mellitus']}]}, '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'}}}}