Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT04211402
Status:
WITHDRAWN
Last Update Posted:
2025-06-05
First Post:
2019-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obsessive-Compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, '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'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Company shifted focus', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06',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': '2019-12-23', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-26', '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 Obsessive-Compulsive Disorder'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obsessive-Compulsive Disorder']}, '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 infection with Obsessive-Compulsive Disorder."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with OCD', '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. OCI greater than or equal to 21\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': 'NCT04211402', 'briefTitle': 'A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obsessive-Compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'ProgenaBiome'}, 'officialTitle': 'A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obsessive-Compulsive Disorder (OCD)', 'orgStudyIdInfo': {'id': 'PRG-029'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obsessive-Compulsive Disorder', 'description': 'Patients with obsessive-compulsive disorder', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'There is no intervention for this study', 'armGroupLabels': ['Obsessive-Compulsive Disorder']}]}, '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'}}}}