Long-term Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis
NCT07154784 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-09-12
Summary
This study aims to perform fecal microbiota transplantation (FMT) and analyze its effects in selected patients aged between 10 and 80 years who have been diagnosed with ulcerative colitis and have been receiving treatment for more than three months at Seoul National University Hospital, Seoul National University Boramae Medical Center, and Seoul National University Bundang Hospital. Through this analysis, the study seeks to identify the long-term efficacy of FMT as a treatment for ulcerative colitis, evaluate the safety of the procedure, and establish a foundation for personalized FMT based on gut microbiota analysis.
Conditions
- Ulcerative Colitis
- Fecal Microbiota Transplantation
Interventions
- BIOLOGICAL
-
Fecal microbiota transplantation (FMT)
Fecal microbiota transplantation (FMT) will be performed at weeks 0 and 4 of study enrollment by administering approximately 250-300 cc of a multi-donor fecal suspension into the colon via sigmoidoscopy, colonoscopy, or by oral administration of an equivalent amount (4 capsules).
Sponsors & Collaborators
-
Seoul National University Bundang Hospital
collaborator OTHER -
Inha University Hospital
collaborator OTHER -
Seoul National University Boramae Hospital
collaborator OTHER -
Seoul National University Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 10 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-19
- Primary Completion
- 2023-07-19
- Completion
- 2027-06-30
Countries
- South Korea
Study Locations
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