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

Seoul National University

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Ulcerative Colitis; Fecal Microbiota Transplantation

Treatments: Biological: Fecal microbiota transplantation (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07154784

2021-0314

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 10 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Ulcerative colitis patient

Experimental group

Description:

This was a multicenter, prospective study that enrolled patients diagnosed with ulcerative colitis who were aged between 10 and 80 years and had been receiving treatment for at least 3 months. Eligible participants were required to meet all of the following inclusion criteria: 1. age between 10 and 80 years; 2. a disease duration of ulcerative colitis of at least 3 months; 3. mild to moderate disease activity, defined by a Mayo score of 4-10 or a partial Mayo score of 2-7; 4. endoscopic evidence of rectal involvement extending ≥5 cm; and 5. willingness to provide written informed consent for participation in the study.

Treatment:

Biological: Fecal microbiota transplantation (FMT)