Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-02 @ 6:50 AM
Study NCT ID:
NCT04100603
Status:
WITHDRAWN
Last Update Posted:
2025-06-05
First Post:
2019-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, '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'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Company focus shifted', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06',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': '2030-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2019-09-20', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing', 'timeFrame': '1 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 with C. diff infection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clostridium Difficile', 'Clostridium Difficile Infection', 'Microbiome', 'CDI']}, '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 C. diff."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with C. difficile infection', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willingness to sign informed consent\n* Diagnosis of C. difficile infection\n* Age of 18 and older\n\nExclusion Criteria:\n\n* Refusal by patient to sign informed consent form\n* Treatment with antibiotics 2 weeks prior to screening\n* Treatment with probiotics 6 weeks prior to screening\n* History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.\n* Postoperative stoma, ostomy, or ileoanal pouch\n* Participation in any experimental drug protocol within the past 12 weeks\n* Treatment with total parenteral nutrition\n* Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial\n* Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study"}, 'identificationModule': {'nctId': 'NCT04100603', 'briefTitle': 'A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection', 'organization': {'class': 'OTHER', 'fullName': 'ProgenaBiome'}, 'officialTitle': 'A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection', 'orgStudyIdInfo': {'id': 'PRG-004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with CDI', 'description': 'Patients who are infected with C. diff', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'There is no intervention for this study', 'armGroupLabels': ['Patients with CDI']}]}, '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': 'Only aggregated deidentified data will be made available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProgenaBiome', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}