To Investigate the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (Assessing the safety of FMT in patients with SIBO)
研究概览
简要总结
Small intestinal bacterial overgrowth (SIBO) is defined as the presence of excessive numbers of bacteria in the small bowel causing gastrointestinal (GI) symptoms. These bacteria are usually coliforms, which are typically found in the colon and include predominantly Gram-negative aerobic and anaerobic species that ferment carbohydrates producing gas .Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. To explore the overall efficacy and safety of FMT in the treatment of SIBO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a positive breath test result upon initial admission.
- •Patients presenting with abdominal symptoms.
- •Patients who have stool and small intestinal fluid samples available before and after FMT.
排除标准
- •Patients with gastrointestinal malignancies.
- •Patients with a history of gastrointestinal surgery.
- •Patients on long-term probiotic use.
- •Patients with a history of extensive antibiotic use.
结局指标
主要结局
Incidence of adverse events (Assessing the safety of FMT in patients with SIBO)
时间窗: 7 days, 1 month
Document adverse events related to FMT that occurred during the study, including their frequency and severity.
Number of Patients with gastrointestinal symptom scores
时间窗: 7 days, 1 month
The efficacy of FMT in SIBO patients was evaluated according to the scores of gastrointestinal symptoms before and after treatment. Patients with gastrointestinal symptom scores, including some of the abdominal symptoms and defecation situation, we can according to this questionnaire to assess patients with abdominal symptoms and defecate on the improvement of their situation.
Investigating the impact of FMT on the colonic and small intestinal microbiota.
时间窗: 7 days, 1 month
For patients before and after the FMT feces and small intestinal juice samples 16 s rRNA sequencing, compare the difference between before and after the FMT feces and bacteria in the intestinal flora of diversity, species composition belong. The changes of commensal bacteria, opportunistic pathogens and pathogenic bacteria in feces and small intestinal fluid after FMT were compared.
次要结局
未报告次要终点
研究者
Huanlong Qin
Clinical Professor
Shanghai 10th People's Hospital