Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT04890405
Status:
UNKNOWN
Last Update Posted:
2021-05-18
First Post:
2021-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Selective Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The assessor of the scale does not know the grouping of patients when assessing the patient.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Diarrhea-type irritable bowel syndrome patients were randomly divided into 2 groups, and each group was given a different treatment method'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-17', 'studyFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2021-05-17', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IBS-SSS score', 'timeFrame': '12 Week after treatment', 'description': 'Severity of irritable bowel syndrome.The score varies from 0 to 500. Higher scores suggest more severe condition.'}], 'secondaryOutcomes': [{'measure': 'Clinical remission rate', 'timeFrame': '2、4、8、12 Week after treatment', 'description': 'Proportion of people in clinical remission after treatment'}, {'measure': 'GSRS score', 'timeFrame': '0、2、4、8、12Week after treatment', 'description': 'Gastrointestinal Symptom Rating Scale.The score varies from 16 to 112. Higher scores suggest more severe gastrointestinal pathology.'}, {'measure': 'IBS-QoL score', 'timeFrame': '0、2、4、8、12Week after treatment', 'description': 'Quality of life score for IBS patients.The score varies from 0 to 136. Higher scores suggest greater impact of disease on life'}, {'measure': 'PHQ-9', 'timeFrame': '0、2、4、8、12Week after treatment', 'description': 'Patient Health Questionnaire-9.The score varies from 0 to 27. Higher scores suggest more severe the depression'}, {'measure': 'GAD-7', 'timeFrame': '0、2、4、8、12Week after treatment', 'description': 'Generalized Anxiety Scale-7.The score varies from 0 to 21. Higher scores suggest heavier the anxiety.'}, {'measure': 'SAS', 'timeFrame': '0、2、4、8、12Week after treatment', 'description': 'Self-rating Anxiety Scale.The score varies from 25 to 100. Higher scores suggest greater degree of anxiety.'}, {'measure': 'SDS', 'timeFrame': '0、2、4、8、12after treatment', 'description': 'Self-rating Depression Scale.The score varies from 25 to 100. Higher scores suggest more severe depression.'}, {'measure': 'Intestinal flora', 'timeFrame': '0、2、4、8、12Week after treatment', 'description': 'Use metagenomics technology to detect intestinal flora'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['irritable bowel syndrome', 'diarrhea', 'Fecal Microbiota Transplantation'], 'conditions': ['Irritable Bowel Syndrome Variant of Childhood']}, 'descriptionModule': {'briefSummary': 'In order to seek a more precise and convenient treatment, we made a self-made precise transplant capsule that is effective against diarrhea. Compared with standardized fecal microbiota transplantation transplantation on the treat of diarrhea-type irritable bowel syndrome. To observe the similarities and differences of the effect between the two treatment methods on the disease. and the changes in intestinal bacteria was also observed.', 'detailedDescription': 'In order to clarify the effectiveness of precision fecal bacteria transplantation, we have independently developed precision transplantation capsules. Seventy patients with diarrhea-type irritable bowel syndrome were selected and randomly divided into 2 groups. The patients in the first group were treated with standard fecal bacteria transplantation once, and the patients in other group were treated with precision transplantation capsules for 28 days. The clinical symptoms of the patients of the two groups were observed before and 2, 4, 8, 12, 24, and 48 weeks after the treatment, and stool samples were collected for intestinal flora detection. The purpose is to observe and compare the efficacy of the two treatment methods and their influence on the intestinal flora.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18 \\~ 75 years.\n* Patients who meet the diagnostic criteria of Rome IV of Irritable Bowel Syndrome and are definitely diagnosed as IBS-D.\n* IBS has been diagnosed for more than 6 months, and has been treated with conventional drugs without obvious curative effect or repeated attacks.\n* No other serious diseases, no mental disorders, and normal communication skills.\n* Sign informed consent and agree to participate in this study.\n* No antibiotics and probiotics were used within one month.\n\nExclusion Criteria:\n\n* Patients are unwilling to participate in this study.\n* Other serious diseases of heart, liver, kidney, respiration, digestion, blood and endocrine system.\n* Combined with intestinal double infection, such as CDI, enterohemorrhagic Escherichia coli, Salmonella, Shigella, Campylobacter, plague, cytomegalovirus, etc.\n* Liver function is significantly abnormal or has the following history of liver disease: AST or ALT is higher than 2 times of the upper limit of normal value, history of liver cirrhosis and hepatic encephalopathy, history of esophageal varices or history of portal shunt.\n* There is evidence of renal function damage or the following history of kidney disease: serum creatinine is 1.5 times higher than the upper limit of normal value; History of dialysis; Or a history of nephrotic syndrome.\n* Patients with various acute infections, tumors, severe arrhythmia, mental system disorders, and drug or alcohol addicts.\n* History of abdominal surgery (except appendicitis, cholecystitis, caesarean section and hysterectomy).\n* Those who were allergic to capsule drugs or contraindications.\n* Lactose intolerance.\n* Clinical researchers who are engaged in other related irritable bowel syndrome at the time of enrollment or within 3 months before enrollment.\n* It is difficult to complete the follow-up, or various factors affecting the compliance.\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT04890405', 'briefTitle': 'Clinical Study of Selective Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Third Military Medical University'}, 'officialTitle': 'Clinical Comparative Study of Precision Flora Transplantation and Standardized Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome.', 'orgStudyIdInfo': {'id': 'TMMU-DP-GI-JZ-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FMT group', 'description': 'Standardized FMT once.Extract all the flora from the feces provided by the donor to make fecal bacteria transplant capsules. The patient took orally on an empty stomach, each time using 3.2g of fecal bacteria.', 'interventionNames': ['Procedure: Standardized FMT']}, {'type': 'EXPERIMENTAL', 'label': 'JZ group', 'description': '1.6g Po perday,for 28 days. probiotics that are effective against diarrhea were selected to make precise flora capsules, which are taken when the patient is on an empty stomach, once a day, using 1.6 g of bacteria per day, orally for 28 consecutive days.', 'interventionNames': ['Combination Product: Precision Flora Transplantation']}], 'interventions': [{'name': 'Standardized FMT', 'type': 'PROCEDURE', 'description': 'The group includes 35 patients. They will receive standardized FMT. Fecal bacteria capsules are used for fecal bacteria transplantation, 16 capsules are used each time, each capsule contains 200mg of fecal bacteria, and it is used orally. It was given only once.', 'armGroupLabels': ['FMT group']}, {'name': 'Precision Flora Transplantation', 'type': 'COMBINATION_PRODUCT', 'description': 'The group includes 35 patients. They will receive Precision Flora Transplantation. They were used self-developed precision transplant capsules for precision flora transplantation. 4 capsules are used each time. Each capsule contains 400mg of various probiotics effective against diarrhea. It is used orally, once a day,for 28 days.', 'armGroupLabels': ['JZ group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yanling Wei', 'role': 'CONTACT', 'email': 'lingzi016@126.com', 'phone': '15310354666'}], 'overallOfficials': [{'name': 'Yanling Wei', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Army Medical Center of PLA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yanling Wei', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Department of Gastroenterology, Da ping Hospital, The Third Military Medical University', 'investigatorFullName': 'Yanling Wei', 'investigatorAffiliation': 'Third Military Medical University'}}}}