Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-03 @ 5:23 AM
Study NCT ID:
NCT04100005
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WITHDRAWN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 Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Company focus shifted', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06',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': '2019-09-20', 'studyFirstSubmitQcDate': '2019-09-20', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Correlation of Microbiome to Crohn's 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 among specific gastrointestinal disease types.'}], 'secondaryOutcomes': [{'measure': 'Validation of Sequencing Methods', 'timeFrame': '1 year', 'description': 'To validate the methods used to sequence samples'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease', 'Crohn Colitis', "Crohn's Ileocolitis", 'Crohn Ileitis', 'Crohn Disease of Ileum', "Crohn's Disease Relapse", "Crohn's Gastritis", 'Crohns Disease Aggravated', 'Crohn Disease in Remission', "Crohn's Jejunitis", "Crohn's Duodenitis", "Crohn's Disease of Pylorus", "Crohn's Esophagitis", "Crohn's"]}, 'descriptionModule': {'briefSummary': "This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Crohn's 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 Crohn's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients who have been diagnosed with Crohn's 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 age 12 and older. (interest is given to children 12 and older to compare with mothers).\n3. Diagnosis of Non-Fistulating Crohn's disease confirmed by at least one of the following\n\n 1. Colonoscopy\n 2. Capsule Endoscopy\n 3. Computerized Tomography (CT) Scan\n 4. Magnetic Resonance Imaging (MRI)\n 5. Balloon-assisted enteroscopy\n\nExclusion Criteria:\n\n1. Refusal to sign informed consent form\n2. Presence of Fistulating Crohn's disease\n3. Treatment with antibiotics within 2 weeks prior to screening\n4. Treatment with probiotics within 6 weeks prior to screening.\n5. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.\n6. Postoperative stoma, ostomy, or ileoanal pouch\n7. Participation in any experimental drug protocol within the past 12 weeks\n8. Treatment with total parenteral nutrition\n9. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial\n10. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study"}, 'identificationModule': {'nctId': 'NCT04100005', 'briefTitle': "A Pilot Study to Explore the Role of Gut Flora in Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'ProgenaBiome'}, 'officialTitle': "A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Crohn's Disease", 'orgStudyIdInfo': {'id': 'PRG-008'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Crohn's disease", 'description': "Patients who have been diagnosed with Crohn's disease", 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'There is no intervention for this study.', 'armGroupLabels': ["Crohn's disease"]}]}, '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': 'UNDECIDED', 'description': 'Only aggregated and deidentified data will be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProgenaBiome', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}