Human Microbiota Transfer Therapy for Depression (The "Moving Moods Pilot Study")

This pilot, randomised controlled trial was an 8-week, triple-blind, 2:1 parallel group, randomised controlled pilot trial (n = 15) assessed the safety and efficacy of faecal microbiota transplant for major depressive disorder (MDD) of enema-delivered FMT treatment (n = 10) compared with a placebo enema (n = 5) in adults with moderate-to-severe MDD, with a 26-week follow-up to monitor longer-term safety. Participants received four FMT or placebo enemas over four consecutive days. The primary aims of the study were to evaluate feasibility and safety of FMT as an adjunctive treatment for MDD in adults. Changes in gut microbiota were assessed as a secondary outcome. Other data were collected, including changes in depression and anxiety symptoms, and safety parameters.

本项为期8周、采用2:1平行分组设计的三盲随机对照先导试验（n=15），针对中度至重度成人重度抑郁症（major depressive disorder, MDD）患者，对比了灌肠式粪菌移植（faecal microbiota transplant, FMT，n=10）与安慰剂灌肠（n=5）的安全性与有效性，并设置26周随访以监测长期安全性。受试者在连续4天内接受4次粪菌移植或安慰剂灌肠给药。本研究的主要目的为评估成人重度抑郁症患者接受粪菌移植作为辅助治疗方案的可行性与安全性。肠道菌群变化作为次要结局指标进行评估。研究同时收集了其他相关数据，包括抑郁与焦虑症状变化及安全性参数。