NCT07154784Enrolling by invitationPhase 2/3
Long-term Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 12 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 8 Jul 2025
- Start date
- 19 Jul 2023
- Primary completion date
- 19 Jul 2023
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Ulcerative colitis
- NCT number
- NCT07154784
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 30
- From 19 Jul 2023 to the primary completion date, 19 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- History of colectomy (excluding appendectomy)
- History of antibiotic use within the past 2 weeks
- Major food allergy
- Comorbid chronic diseases such as chronic liver disease, heart failure, or chronic obstructive pulmonary disease (COPD)
- Any other condition deemed inappropriate for study participation by the investigator
Lab values
- Neutropenia (absolute neutrophil count \< 500)
Other
- Hospitalization due to acute severe ulcerative colitis (Mayo score 11-12)
- Pregnancy
- Infectious colitis not caused by Clostridioides difficile
- Indeterminate colitis
- Refusal to participate in the study
Who the study is looking for
- 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
Age in the registry: 10 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.