Status:
ENROLLING_BY_INVITATION
Long-term Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Seoul National University Bundang Hospital
Inha University Hospital
Conditions:
Ulcerative Colitis
Fecal Microbiota Transplantation
Eligibility:
All Genders
10-80 years
Phase:
PHASE2
PHASE3
Brief 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 bee...
Detailed Description
The pathogenesis of inflammatory bowel disease (IBD) is thought to result from a complex interplay of genetic predisposition, environmental factors such as diet and gut microbiota, and immunological m...
Eligibility Criteria
Inclusion
- Age between 10 and 80 years
- History of ulcerative colitis for at least 3 months
- Mild to moderate ulcerative colitis with a Mayo score of 4-10 or a partial Mayo score of 2-7
- Endoscopic evidence of rectal involvement extending at least 5 cm
- Willingness to provide written informed consent for participation in this clinical trial
Exclusion
- Hospitalization due to acute severe ulcerative colitis (Mayo score 11-12)
- Neutropenia (absolute neutrophil count \< 500)
- Pregnancy
- Infectious colitis not caused by Clostridioides difficile
- History of colectomy (excluding appendectomy)
- History of antibiotic use within the past 2 weeks
- Use of corticosteroids \> 20 mg within the past 4 weeks
- Current or planned use of biologics (e.g., anti-TNF-α antibodies, anti-α4β7 integrin monoclonal antibodies, JAK inhibitors, anti-IL-12/IL-23 antibodies)
- Major food allergy
- Indeterminate colitis
- Comorbid chronic diseases such as chronic liver disease, heart failure, or chronic obstructive pulmonary disease (COPD)
- Refusal to participate in the study
- Any other condition deemed inappropriate for study participation by the investigator
Key Trial Info
Start Date :
July 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07154784
Start Date
July 19 2023
End Date
June 30 2027
Last Update
September 12 2025
Active Locations (1)
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1
Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine
Seoul, Dongjak-gu, South Korea, 07061