Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT06166667
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2023-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Fecal Capsule on Chronic Kidney Disease (CKD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2023-05-06', 'studyFirstSubmitQcDate': '2023-12-03', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abundance of gut microbiota', 'timeFrame': '6 months after the end of the trial', 'description': 'Fecal sample metagenomic sequencing'}], 'secondaryOutcomes': [{'measure': '24-hour urine protein quantitative change rate', 'timeFrame': '6 months after the end of the trial', 'description': 'Urine sample'}, {'measure': 'the density of immune cells', 'timeFrame': '6 months after the end of the trial', 'description': 'Blood samples'}, {'measure': 'Cytokine concentration', 'timeFrame': '6 months after the end of the trial', 'description': 'Blood samples'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Insufficiency, Chronic']}, 'descriptionModule': {'briefSummary': 'By collecting blood, urine and stool samples before and after oral Enterobacteriaceae capsule (FMT) from CKD subjects, we investigated the role and related mechanisms of gut microecology in the development of CKD using a combination of metagenomic sequencing, metabolomic analysis and flow cytometry.', 'detailedDescription': 'Patients involved in the trial received 16 capsules of Enterobacteriaceae (one course) on days 1, 8, and 15, which were provided by Dongyuan Yikang company. Patients were prohibited from taking antibiotics such as amoxicillin and Cefalexin during the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects: Patients with chronic kidney disease (CKD)\n2. GFR ≥ 30 ml / min, or serum creatinine ≤ 442 μ mol/L\n3. Negative urine pregnancy test and no plans for pregnancy for the next 18 months, enabling effective contraception\n4. Age: 18-70 years\n5. Signed informed consent for clinical studies informed consent for treatment of patients with flora transplantation (FMT)\n\nExclusion Criteria:\n\n1. Had taken antibiotics for nearly 14 days\n2. Active systemic infections or severe infections within 1 month prior to enrollment, including HIV, HBV, HCV\n3. White blood cell count \\< 3.0x109/l; Platelet count \\< 80x109 / L, or had other hematologic diseases\n4. Presence of malignancy and other diseases with expected survival time \\< 3 months\n5. Presence of IBD, CDI, or gastrointestinal tumors\n6. Presence of active gastrointestinal bleeding or acute and chronic gastrointestinal inflammation\n7. Were or had undergone FMT\n8. Psychosis and cognitive impairment\n9. History of alcohol or drug abuse\n10. Pregnant or lactating women\n11. Difficult to follow-up\n12. Difficult or unwilling to cooperate'}, 'identificationModule': {'nctId': 'NCT06166667', 'briefTitle': 'Effect of Fecal Capsule on Chronic Kidney Disease (CKD)', 'organization': {'class': 'OTHER_GOV', 'fullName': "Shanxi Provincial People's Hospital"}, 'officialTitle': 'Effect of Fecal Capsule on Chronic Kidney Disease (CKD)', 'orgStudyIdInfo': {'id': '(2022) SYKLSZ No.352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'Fecal Microbiota Transplant', 'interventionNames': ['Procedure: Fecal Microbiota Transplant（FMT）']}], 'interventions': [{'name': 'Fecal Microbiota Transplant（FMT）', 'type': 'PROCEDURE', 'description': 'Patients involved in the trial received 20 capsules of Enterobacteriaceae (one course) on days 1, 8, and 15, which were provided by Dongyuan Yikang company. Patients were prohibited from taking antibiotics such as amoxicillin and Cefalexin during the trial.', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '030012', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': "Shanxi Provincial People's Hospita", 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'overallOfficials': [{'name': 'Yafeng Li, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanxi Provincial People's Hospital (Fifth Hospital) of Shanxi Medical University"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'After the study is completed', 'ipdSharing': 'YES', 'description': 'After the study is completed，ResMan,http://www.medresman.org.cn', 'accessCriteria': 'Nephrologist'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanxi Provincial People's Hospital", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}