Fecal microbiota transplantation in patients with slow-transit constipation: A randomized, clinical trial

Fecal microbiota transplantation has been proposed as a therapeutic approach for chronic constipation. This randomized, controlled trial aimed to compare the effects of conventional treatment alone (control) with additional treatment with FMT (intervention) in patients with slow-transit constipation (STC). Adults with STC were randomized to receive intervention or control treatment. The control group received education, behavioral strategies, and oral laxatives. The intervention group was additionally provided 6 days of FMT. The primary endpoint was the clinical cure rate (proportion of patients achieving a mean of ≥ three complete spontaneous bowel movements [CSBMs] per week]. Secondary outcomes and safety parameters were assessed throughout the study. Sixty patients were randomized to either conventional treatment alone (n = 30) or FMT (n = 30) through a nasointestinal tube. There were significant differences between the intervention group and control group in the clinical improvement rate (intention-to-treat [ITT]: 53.3% vs. 20.0%, P = 0.009), clinical cure rate (ITT: 36.7% vs. 13.3%, P = 0.04), mean number of CSBMs per week (ITT: 3.2 ± 1.4 vs. 2.1 ± 1.2, P = 0.001), and the Wexner constipation score (ITT: 8.6 ± 1.5 vs. 12.7 ± 2.5, P P P粪便微生物群移植（Fecal microbiota transplantation, FMT）已被提议作为慢性便秘的治疗手段。本随机对照试验旨在对比单纯常规治疗（对照组）与联合粪便微生物群移植干预（干预组）在慢传输型便秘（slow-transit constipation, STC）患者中的治疗效果。入组的慢传输型便秘成年患者被随机分配至干预组或对照组接受对应治疗。对照组接受健康宣教、行为干预及口服泻药治疗；干预组在此基础上额外接受为期6天的粪便微生物群移植治疗。本研究的主要终点为临床治愈率，即每周平均完全自发性排便次数（complete spontaneous bowel movements, CSBMs）≥3次的患者占比。整个研究过程中均对次要结局指标与安全性参数进行评估。共计60例患者通过鼻肠管给药，被随机分配至单纯常规治疗组（n=30）或粪便微生物群移植组（n=30）。干预组与对照组在临床改善率[意向性治疗（intention-to-treat, ITT）分析：53.3% vs. 20.0%，P=0.009]、临床治愈率（ITT分析：36.7% vs.13.3%，P=0.04）、每周平均完全自发性排便次数（ITT分析：3.2±1.4 vs.2.1±1.2，P=0.001）以及Wexner便秘评分（ITT分析：8.6±1.5 vs.12.7±2.5，P P P）间均存在显著差异。