Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-01 @ 9:57 AM
Study NCT ID:
NCT05714566
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on Gut Microbiome and Metabolomics Alterations in C.Difficile Infected IBD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D065817', 'term': 'Congenital Microtia'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C.difficile positive', 'timeFrame': '1 day', 'description': 'C.difficile toxin test is positive'}, {'measure': 'C.difficile negative', 'timeFrame': '1 day', 'description': 'C.difficile toxin test is negative'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory bowel disease', 'Clostridium difficile disease'], 'conditions': ['Inflammatory Bowel Diseases', 'Clostridium Difficile Infections', 'Microtia']}, 'descriptionModule': {'briefSummary': "The goal of this research is to compare alterations of gut microbiota and fecal metabolomics alterations between inflammatory bowel disease patients infected with or without Clostridioides difficile. The main questions it aim to answer are: which bacterial genus or fecal metabolites can discriminate IBD patients infected or more likely to be infected with Clostridioides difficile and their role in the pathogenesis of Clostridioides difficile.\n\ntype of study: observational study participant population/health conditions\n\n1. population diagnosed with Ulcerative colitis or Crohn's disease\n2. Having diarrhea Participants will be included in this research. If there is a comparison group: Researchers will compare healthy people without IBD or any diarrhea to see if disease or diarrhea would affect the gut microbiota and metabolites."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "1. IBD group: inpatients diagnosed with ulcerative colitis or Crohn's disease.\n2. IBD+CDI group: IBD patients positive for C.difficile toxin and having diarrhea\n3. Health control: people without diarrhea or any other intestinal diseases and negative for C.difficile toxin tests", 'eligibilityCriteria': "Inclusion Criteria:\n\n* inpatients diagnosed with ulcerative colitis or Crohn's disease in Renji hospital\n* age from 18 to 75 years old\n\nExclusion Criteria:\n\n* other infection caused diarrhea\n* other metabolic diseases or inflammatory diseases\n* patients who are not able to send back samples 4-6 weeks after therapy"}, 'identificationModule': {'nctId': 'NCT05714566', 'briefTitle': 'Research on Gut Microbiome and Metabolomics Alterations in C.Difficile Infected IBD Patients', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Research on Biomarkers of Clostridioides Difficile Infection in Inflammatory Bowel Disease Patients Defined by Gut Microbiome and Fecal Metabolomics Alterations', 'orgStudyIdInfo': {'id': 'LY2022-059-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IBD', 'interventionNames': ['Diagnostic Test: Clostridioides difficile toxin detection']}, {'label': 'IBD+CDI', 'interventionNames': ['Diagnostic Test: Clostridioides difficile toxin detection']}, {'label': 'Health control', 'interventionNames': ['Diagnostic Test: Clostridioides difficile toxin detection']}], 'interventions': [{'name': 'Clostridioides difficile toxin detection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Using Genexpert kit to detect the stool samples of IBD patients. If C. difficile toxin is positive, the patient is assigned to IBD+CDI group, or else assigned to IBD group. Every sample assigned to Health control group should have negative results for C.difficile toxin tests.', 'armGroupLabels': ['Health control', 'IBD', 'IBD+CDI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang', 'role': 'CONTACT', 'email': '15828660135@163.com', 'phone': '13262906006'}, {'name': 'Li', 'role': 'CONTACT', 'email': 'ruth_limin@126.com', 'phone': '13918363998'}], 'facility': 'Shanghai jiaotong university, school of medicine, affliated Renji hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yang', 'role': 'CONTACT', 'email': '15828660135@163.com', 'phone': '13262906006'}], 'overallOfficials': [{'name': 'Min Li, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'gut microbiota and metabolites change'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}