Data

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

Deakin University

Dataset description

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.
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Related Study

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

Brief Summary

This study will evaluate the feasibility of Human Microbiota Transfer Therapy (HMTT) for depression in adults. We will aim to recruit 15 participants to recieve a HMTT enema (n=10) or placebo enema (n=5). We will follow up participants for 8 weeks for primary outcome, measures including recruitment, retention, acceptibility, tolerability, and 6 months for safety data. We hypothesise that HMTT will be a safe and feasible treatment for depression in adults. This pilot data will inform a larger randomised controlled trial evaluating efficacy of HMTT for depression, scheduled to commence in 2022.

Conditions

Condition Codes

Intervention Code

Inclusion Criteria

  • • Adults (age 18-65) • MDD according to Structured Clinical Interview for DSM-5 (SCID-5) MDD module • Moderate-to-severe score on MADRS (i.e. score of greater than or equal to 20) • Have been on stable pharmaceutical treatment for MDD for one month prior to commencing trial

Study Type

  • Interventional

Ethics Approval

Study Protocol: Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

No

What data in particular will be shared?

When will data be available?

Available to whom?

Available for what types of analyses?