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.