Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-04-13 @ 9:38 PM
Study NCT ID:
NCT02399618
Status:
UNKNOWN
Last Update Posted:
2016-05-25
First Post:
2015-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Freeze-dried, Capsulized FMT for RCDI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-24', 'studyFirstSubmitDate': '2015-03-21', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety is assessed by clinical symptoms, exam, signs (GI and systemic).', 'timeFrame': 'Up to 3 months post-FMT', 'description': 'Safety is assessed by clinical symptoms, exam, signs (GI and systemic).'}, {'measure': 'Efficacy', 'timeFrame': 'Up to 3 months post-FMT', 'description': 'Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile.'}], 'secondaryOutcomes': [{'measure': 'Change of fecal bacteriology', 'timeFrame': 'Up to 1 month post-FMT', 'description': 'Fecal microbiology is characterized by 16S rRNA gene-based analysis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Clostridium difficile Infection', 'Fecal Microbiota Transplantation', 'Freeze-dried', 'Acid-resistant Capsules'], 'conditions': ['Clostridium Difficile Infection']}, 'descriptionModule': {'briefSummary': 'Recurrent or refractory Clostridium difficile Infection (RCDI), with a recent increased incidence, is one of the most difficult and increasingly challenges for CDI. Since Fecal Microbiota Transplantation (FMT) has been accepted as the first-line therapy for RCDI, it is prudent to consider less invasive and more convenient means of administering FMT. The majority of reported FMT procedures have been performed with fresh or frozen stool suspensions via colonoscopy or nasojejunal tube. Nowadays, using acid-resistant hypromellose capsules, Youngster et al. significantly simplified the clinical practice of FMT and removed the need for invasive gastrointestinal procedures. However, to avoid undesirable disintegration, those capsules containing stool suspensions must be kept frozen all the time, which extremely limits their widespread application. The purpose of this study is to evaluate the efficacy and safety of freeze-dried, capsulized FMT for RCDI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with refractory, recurrent or relapsing C. difficile infection (RCDI), as defined in guidelines as a relapse of CDI after having at least 3 episodes of mild to moderate CDI and failure of a 6- to 8-week taper with vancomycin with or without an alternative antibiotic or at least 2 episodes of severe CDI resulting in hospitalization and associated with significant morbidity;\n* Willingness to accept risk of healthy unrelated donor stool.\n\nExclusion Criteria:\n\n* Delayed gastric emptying syndrome;\n* Known chronic aspiration;\n* Swallowing dysfunction or oral-motor dyscoordination;\n* Pregnant or breast-feeding women;\n* Usage of probiotics, prebiotics or synbiotics within the last month;\n* Smoking or alcohol use within the last month;\n* Patients with an exacerbation of condition not because of CDI;\n* Patients on major immunosuppressive agents or with any other cause of severe immunodeficiency;\n* Patients with a history of significant allergy because of diet;\n* Patients on any agents affecting fecal bacteriology because of comorbidities.'}, 'identificationModule': {'nctId': 'NCT02399618', 'briefTitle': 'Freeze-dried, Capsulized FMT for RCDI', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'Freeze-dried, Capsulized Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection', 'orgStudyIdInfo': {'id': 'Freeze-dried FMT-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capsulized freeze-dried FMT', 'description': 'Reconstitution of normal flora with capsulized freeze-dried fecal inoculum', 'interventionNames': ['Drug: Fecal Microbiota Transplantation']}], 'interventions': [{'name': 'Fecal Microbiota Transplantation', 'type': 'DRUG', 'otherNames': ['Fecal bacteriotherapy'], 'description': 'Fecal microbiota transplant from healthy, unrelated donor via freeze-dried capsule', 'armGroupLabels': ['Capsulized freeze-dried FMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chao Ding, MD candidate', 'role': 'CONTACT', 'email': 'dingcaho199105121@126.com', 'phone': '+86-25-80860036'}, {'name': 'Ning Li, MD', 'role': 'CONTACT', 'email': 'liningrigs@vip.sina.com', 'phone': '+86-25-80860089'}], 'facility': 'Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Chao Ding, MD candidate', 'role': 'CONTACT', 'email': 'dingchao19910521@126.com', 'phone': '+86-25-80860036'}, {'name': 'Ning Li, MD', 'role': 'CONTACT', 'email': 'liningrigs@vip.sina.com', 'phone': '+86-25-80860089'}], 'overallOfficials': [{'name': 'Ning Li, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinling Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD candidate', 'investigatorFullName': 'Ding Chao', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}