Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT02889627
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2016-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation for Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2016-08-30', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of the seizures', 'timeFrame': '3months', 'description': 'the rates of patients who achieved a ≥50% reduction in seizure frequency from baseline to one month after WMT'}], 'secondaryOutcomes': [{'measure': 'gut microbiota analysis', 'timeFrame': 'baseline, 1 week-post-FMT, 1 months-post-FMT, 3 months-post-FMT', 'description': 'The stool samples of participants before and after FMT were collected and analized, by 16S rRNA and were used to investigate the crucial microbiota for devising a more efficient treatment strategy for epilepsy.'}, {'measure': 'Adverse events', 'timeFrame': '3months', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after FMT.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fecal Microbiota Transplantation', 'Gut microbiota', 'Brain-gut axis', 'Epilepsy'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '24315484', 'type': 'BACKGROUND', 'citation': 'Hsiao EY, McBride SW, Hsien S, Sharon G, Hyde ER, McCue T, Codelli JA, Chow J, Reisman SE, Petrosino JF, Patterson PH, Mazmanian SK. Microbiota modulate behavioral and physiological abnormalities associated with neurodevelopmental disorders. Cell. 2013 Dec 19;155(7):1451-63. doi: 10.1016/j.cell.2013.11.024. Epub 2013 Dec 5.'}, {'pmid': '22183182', 'type': 'BACKGROUND', 'citation': 'Borody TJ, Khoruts A. Fecal microbiota transplantation and emerging applications. Nat Rev Gastroenterol Hepatol. 2011 Dec 20;9(2):88-96. doi: 10.1038/nrgastro.2011.244.'}, {'pmid': '26939622', 'type': 'BACKGROUND', 'citation': 'Cui B, Li P, Xu L, Peng Z, Xiang J, He Z, Zhang T, Ji G, Nie Y, Wu K, Fan D, Zhang F. Step-up fecal microbiota transplantation (FMT) strategy. Gut Microbes. 2016 Jul 3;7(4):323-328. doi: 10.1080/19490976.2016.1151608. Epub 2016 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'Increasing evidences showed the microbiota effects on neuropsychiatric disorders. This clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation for epilepsy.', 'detailedDescription': 'Very few literatures reported the clinical use of microbiota or bacteria for brain diseases. The most effective strategy for reconstruction of gut microbiota should be fecal microbiota transplantation (FMT). This study aims to evaluate the efficacy and safety of FMT for epilepsy. Patients were diagnosed as epilepsy by electroencephalogram (EEG) and MRI and clinical data when the study began and thent received repeated FMT with fecal from healthy donors.The antiepileptic medication regimen of patients remained unchanged after FMT. The primary outcome measure was the frequency of the seizures. Secondary outcome measure were the 50% response rate.\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nhad been diagnosed with epilepsy for at least three months; experienced at least one seizure during the three months before WMT ;\n\nExclusion Criteria:\n\nhad other severe diseases, including other intestinal disorders (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure or serious liver or kidney disease, had undergone previous FMT or WMT, had taken antibiotics within three months before starting WMT'}, 'identificationModule': {'nctId': 'NCT02889627', 'briefTitle': 'Fecal Microbiota Transplantation for Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Nanjing Medical University'}, 'officialTitle': 'Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy', 'orgStudyIdInfo': {'id': 'Epilepsy-CN-160816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FMT with microbiota suspension', 'description': 'Participants undergo repeated FMT with \\~50ml microbiota suspension.', 'interventionNames': ['Drug: Fecal microbiota suspension']}], 'interventions': [{'name': 'Fecal microbiota suspension', 'type': 'DRUG', 'otherNames': ['Washed fecal microbiota'], 'description': "The prepared microbiota suspension was infused into the participates' mid-gut or lower gut.", 'armGroupLabels': ['FMT with microbiota suspension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210011', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Faming Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '086-25-58509883'}], 'facility': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Faming Zhang, MD,PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '086-25-58509883'}], 'overallOfficials': [{'name': 'Faming Zhang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, Gastroenterology', 'investigatorFullName': 'Faming Zhang', 'investigatorAffiliation': 'The Second Hospital of Nanjing Medical University'}}}}