Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-03 @ 11:15 AM
Study NCT ID:
NCT03014505
Status:
UNKNOWN
Last Update Posted:
2017-01-09
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation for Decompensated Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-06', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-01-06', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events complication rate in all patients in both groups', 'timeFrame': '3 months', 'description': 'Adverse events like the general situation, defecate situation and possible clinical events, including: Incidence of new onset upper gastrointestinal bleed in both groups; development of new onset of ascites in both groups.; Number of Spontaneous Bacterial peritonitis cases in both groups. Acute on Chronic Liver failure cases in both groups.'}], 'secondaryOutcomes': [{'measure': 'Improvement in liver function test as compared to baseline in both groups.', 'timeFrame': '3 months'}, {'measure': 'Reduction in systemic inflammatory markers like TNF-α in both groups.', 'timeFrame': '3 months'}, {'measure': 'Reduction in systemic inflammatory markers like IL-6 in both groups.', 'timeFrame': '3 months', 'description': 'Improvement is defined as improvement in Intestinal mucosa structure pre and post treatment.'}, {'measure': 'Reduction in systemic inflammatory markers like serum endotoxins in both groups.', 'timeFrame': '3 months'}, {'measure': 'Diamine oxidase（DAO）', 'timeFrame': '3 months'}, {'measure': 'Histological changes in the intestinal biopsy in both groups.', 'timeFrame': '3 months'}, {'measure': 'Microbiota composition', 'timeFrame': '3 months', 'description': 'Deep sequencing of the microbiota at baseline and post-FMT.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cirrhosis', 'Fecal Microbiota Transplantation', 'Intestinal flora', 'Intestinal mucosal barrier', 'Intestinal Bacteria Flora Disturbance'], 'conditions': ['Decompensated Cirrhosis', 'Fecal Microbiota Transplantation']}, 'descriptionModule': {'briefSummary': 'Imbalance of gut bacteria is suspected to play a key role driving the progression of cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will determine if fecal microbiota transplantation is an effective and safe treatment for decompensated cirrhosis.', 'detailedDescription': 'Two groups of inpatients with decompensated cirrhosis will be randomized using random sequence generator into experimental and control groups. Two groups will given traditional treatments and experimental group will added treatment with fecal microbiota transplantation via endoscope and/or cenema.The liver function parameters, adverse events complication, systemic inflammatory markers, Intestinal mucosa structure, permeability changes in the intestinal mucosal barrier, Microbiota composition will be assessed and thereafter at 1 month and 3 months \\& subjects will be clinically assessed for improvement or worsening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\>18 years of age\n2. Agreed to participate in this clinical study and signed informed consent, follow-up time greater than 3 months.\n3. Comply with the diagnostic criteria of decompensated liver cirrhosis, including liver function damage, portal hypertension clinical manifestations, laboratory and imaging studies.\n\nExclusion Criteria:\n\n1. Ongoing bacterial infection requiring antibiotic treatment.\n2. current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average).\n3. consecutive months within 1 year prior to screening.\n4. Treatment with antibiotics or probiotics in the preceding 3 months.\n5. Inability to safely perform an GastroIntestinal endoscopy.\n6. No history of recent spontaneous bacterial peritonitis or gastrointestinal bleeding.(14 days).\n7. Human Immunodeficiency Virus (HIV) infection.\n8. Active, serious medical disease with likely life expectancy less than 5 years.\n9. Active substance abuse including inhaled or injection drugs in the year prior to screening.\n10. pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding.\n11. Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study.\n12. History of severe (anaphylactic) food allergy.\n13. History of gastroparesis or altered gastric motility -\n14. Psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT03014505', 'acronym': 'FMTDC', 'briefTitle': 'Fecal Microbiota Transplantation for Decompensated Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chengdu Medical College'}, 'officialTitle': 'Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FMT-GYH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FMT', 'description': 'Fecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments', 'interventionNames': ['Biological: FMT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The traditional treatments', 'interventionNames': ['Other: traditional treatments']}], 'interventions': [{'name': 'FMT', 'type': 'BIOLOGICAL', 'otherNames': ['Fecal Microbiota Transplantation'], 'description': 'Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1', 'armGroupLabels': ['FMT']}, {'name': 'traditional treatments', 'type': 'OTHER', 'description': 'traditional treatments for Decompensated Cirrhosis in part 2', 'armGroupLabels': ['The traditional treatments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610500', 'city': 'Chendu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao-an Li, doctor', 'role': 'CONTACT', 'email': 'zqzy1983@163.com', 'phone': '+8613680868858'}], 'facility': 'IEC of Chengdu Medical College', 'geoPoint': {'lat': 30.92504, 'lon': 121.03163}}], 'centralContacts': [{'name': 'Yan Zhou, Ph.D', 'role': 'CONTACT', 'email': 'zqlvzy319@163.com', 'phone': '+86-18981941992'}], 'overallOfficials': [{'name': 'Xiao-an Li, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Chengdu Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chengdu Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}