Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT04900051
Status:
UNKNOWN
Last Update Posted:
2021-05-25
First Post:
2021-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Efficacy and Safety of Fecal Microbiota Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin), Fecal calprotectin, Stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-19', 'studyFirstSubmitDate': '2021-03-31', 'studyFirstSubmitQcDate': '2021-05-19', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Set up a FMT registry', 'timeFrame': '3 years', 'description': 'Set up a registry of FMT in diseases known to be associated with intestinal microbial imbalance'}], 'secondaryOutcomes': [{'measure': 'Patient outcome of FMT', 'timeFrame': '6 month', 'description': 'Compare the severity of diseases, any adverse event before and after FMT'}, {'measure': 'Developing biobank of FMT', 'timeFrame': '3 Years', 'description': 'Collect the study sample of microbium from donors and recipients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fecal Microbiota Transplantation']}, 'descriptionModule': {'briefSummary': 'Changes in the fecal microbiota are known to be involved in the etiology of several diseases. The purpose of this study is to evaluate the effectiveness and safety of fecal microbiota transplantation (FMT) in diseases known to be associated with intestinal microbial inbalance. .', 'detailedDescription': 'This registry will prospectively enroll 300 patients who undergo fecal microbiota transplantation(FMT) at 3 clinical center (Yeungnam university mecial center, Kyungpook national university hospital, Keimyung university dongsan medical center). Feces received from healthy donors are prepared as frozen feces according to a standardized protocol, and transplanted to recipients within 3 months. Next generation sequencing(NGS) is used to check the characteristics of the fecal microbiota of the donor stool, and to evaluate the efficacy by checking the change in the fecal microbium of recipient before and after transplantation. The data is documented for following diseases known to be related to microbium imbalance.\n\n1. Recurrent or Refractory CDI Abdominal symptoms questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin)\n2. Irritable bowel syndrome, Functional dyspepsia Abdominal symptoms questionnaires, IBS diagnosis and food-related questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin)\n3. Inflammatory Bowel Disease Abdominal symptoms questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin), fecal calprotectin, Colonoscopic examination(Mayo endoscopic subscore, CD-SES)\n4. Non-alcoholic steatohepatitis, NASH Abdominal symptoms questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin), BMI check\n5. Obesity Abdominal symptoms questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin), BMI check'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Hospitalized and outpatient aged from 18 to 80 years old\n* Those who agrees after hearing the explanation on the efficacy and safety of fecal microbiota transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those who have been diagnosed with disease to be studied and do not respond to exist treatments\n\n 1. Ulcerative colitis, Crohn disease : Patient who does not responding to anti- TNF treatment for more than 3 month.\n 2. Irritable bowel syndrome, Functional dyspepsia : Patient who does not responding to pharmacological therapies and serotonin uptake inhibitor for more than 6 month.\n 3. Recurrent of Refractory CDI, NASH, Obesity : Patient who does not responding to treatment for more than 6 month.\n\nExclusion Criteria:\n\n* Neutrophil (\\<0.5 x 10\\*9/L)\n* Leukocytosis (\\> 30.0 x 10\\*9/L)\n* Toxic megacolon confirmed in abdomen Xray\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT04900051', 'briefTitle': 'Clinical Efficacy and Safety of Fecal Microbiota Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Keimyung University Dongsan Medical Center'}, 'officialTitle': 'Clinical Efficacy and Safety of Fecal Microbiota Transplantation', 'orgStudyIdInfo': {'id': '2020-08-016'}}, 'contactsLocationsModule': {'locations': [{'zip': '700-712', 'city': 'Daegu', 'state': 'Jung-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yoo Jin Lee', 'role': 'CONTACT', 'email': 'doctorlyj@naver.com', 'phone': '+82-250-7088'}], 'facility': 'KeimyungUniversity', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'centralContacts': [{'name': 'Yoo Jin Lee, Professor', 'role': 'CONTACT', 'email': 'doctorlyj@naver.com', 'phone': '+82-53-250-7163'}], 'overallOfficials': [{'name': 'Lee Yoo Jin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keimyung University Dongsan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'YooJin Lee', 'investigatorAffiliation': 'Keimyung University Dongsan Medical Center'}}}}