Long-term Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Co-primary outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ulcerative colitis patient
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:
- age between 10 and 80 years;
- a disease duration of ulcerative colitis of at least 3 months;
- mild to moderate disease activity, defined by a Mayo score of 4-10 or a partial Mayo score of 2-7;
- endoscopic evidence of rectal involvement extending ≥5 cm; and
- willingness to provide written informed consent for participation in the study.
干预措施: Fecal microbiota transplantation (FMT) (Biological)
结局指标
主要结局
Co-primary outcome
时间窗: 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. 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 2. Steroid-free Clinical Remission at Week 12 Mayo score ≤2 and no subscore \>1, without steroid use. Unit: Participants
次要结局
- Co-secondary outcome(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]).)
研究者
KwangWoo Kim
Professor
Seoul National University Hospital