Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07154784

Long-term Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Fecal Microbiota Transplantation Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine

Seoul, Dongjak-gu, 07061, South Korea

About this study

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 mechanisms. Among these, increasing attention has been given to the role of the gut microbiota, which resides on the intestinal mucosal surface and plays a key role in regulating host immune responses. Emerging evidence suggests that alterations in gut microbiota, as well as viruses that influence microbial composition, are closely associated with IBD.

In 2013, a landmark study published in the New England Journal of Medicine demonstrated that fecal microbiota transplantation (FMT)-a procedure in which processed stool from a healthy donor is delivered into a patient's colon via colonoscopy-significantly reduced the recurrence of antibiotic-associated Clostridioides difficile infection. Since then, FMT has been actively studied, particularly for its therapeutic potential in ulcerative colitis, a subtype of IBD.

Randomized controlled trials have investigated various methods of FMT delivery in ulcerative colitis, including colonoscopy, sigmoidoscopy, and oral capsules. No significant differences in efficacy have been reported between endoscopic and oral routes. In a domestic study on multidrug-resistant organisms, oral capsules showed promising outcomes in restoring microbial balance when compared with endoscopy and nasogastric tube administration.

While FMT delivery methods in Western countries are evolving from inpatient colonoscopic administration to outpatient enema or capsule-based regimens, South Korea currently lacks clinical research infrastructure for FMT beyond case reports. Although a few cases of FMT in IBD patients have been documented, no center has conducted formal clinical trials.

Therefore, this study aims to evaluate the clinical efficacy and underlying mechanisms of FMT in Korean patients with IBD, especially those with ulcerative colitis. Through this investigation, we seek to clarify the long-term therapeutic potential and safety of fecal microbiota transplantation in this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Fecal Microbiota Transplantation (FMT)

Biological

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).

Primary outcomes

  1. Co-primary outcome

    Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).

    • Steroid-free Clinical Response at Week 12 Mayo score ≥3 and ≥30% ↓ from baseline, with rectal bleeding subscore ↓ ≥1 or ≤1, without steroid use.

    Unit: Participants

    • Steroid-free Clinical Remission at Week 12 Mayo score ≤2 and no subscore >1, without steroid use. Unit: Participants

Secondary outcomes

  1. Co-secondary outcome

    Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).

    1.Clinical Response at Week 12 and 48 Mayo ≥3 and ≥30%↓, rectal bleeding subscore ↓≥1 or ≤1. Unit: Participants

  2. Co-secondary outcome

    Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).

    2.Clinical Remission at Week 12 and 48 Mayo ≤2 and all subscores ≤1. Unit: Participants

  3. Co-secondary outcome

    Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).

    3.Endoscopic Response at Week 12 and 48 Mayo endoscopic subscore ↓≥1 from baseline. Unit: Participants

  4. Co-secondary outcome

    Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).

    4.Endoscopic Remission at Week 12 and 48 Mayo endoscopic subscore = 0. Unit: Participants

  5. Co-secondary outcome

    Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).

    5.CRP Change at Week 12 and 48 Change in serum CRP from baseline. Unit: mg/dL

  6. Co-secondary outcome

    Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).

    6.ESR Change at Week 12 and 48 Change in ESR from baseline. Unit: mm/hr

  7. Co-secondary outcome

    Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).

    7.Fecal Calprotectin Change at Week 12 and 48 Change from baseline. Unit: mg/kg

  8. Co-secondary outcome

    Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).

    8.Microbiome Change at Week 12 and 48 Change in % relative abundance via 16S rRNA or shotgun. Unit: % relative abundance

  9. Co-secondary outcome

    Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).

    9.Cytokine Change at Week 12 and 48 Change in mucosal cytokine levels from baseline. Unit: pg/mL

  10. Co-secondary outcome

    Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).

    10.Single-cell RNA Expression Change at Week 12 and 48 Change in gene expression from serum (scRNA-seq). Unit: Fold change

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Inha University Hospital
  • Seoul National University Boramae Hospital
  • Seoul National University Bundang Hospital

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2027
First posted
Sep 4, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.