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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Source Study

Trial acronym

Not available

Trial ID

ACTRN12621000932864

Purpose

Treatment

Phase

Not Applicable

Funding

Charities/Societies/Foundations,Wilson Foundation

Scientific enquiries

Dr Jessica Green

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 ran ....
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Key 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

Key Exclusion Criteria

• Active suicidality (a MADRS suicide item score of 5 or 6) • Use of probiotics, antibiotics or any experimental drug in the one month prior to study entry • Serious gastrointestinal conditions (including inflammatory bowel disease, bowel cancer, diverticular disease, or a history of major bowel surgery, but not including irritable bowel syndrome, chronic diarrhoea or constipation) • Pregnancy or breastfeeding (pregnancy will be determined in females using a urine pregnancy test at baseline) • C ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    15

Min. age    18 Years

Max. age    65 Years

Sex    Both males and females

Condition category    Major Depressive Disorder

Condition code    Mental Health

Intervention

Intervention code Treatment: Other

Faecal Microbiota Transplantation via enema, referred to in this study as Human Microbiota Transfer Therapy (HMTT) Participants will recieve four doses of HMTT via enema over four consecutive days. Each dose will consist of a 50mL volume of faecal suspension, combined with 10% glycerol delivered into the rectum via a syringe. Participants will be required to retain the enema for thirty minutes. The HMTT will be delivered by a study nurse in a hospital environment. Delivery and direct obsersvatio ....
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Comparison

Control group Placebo

identical placebo product comprised of normal saline solution, 10% glycerol and brown dye

Outcomes

Outcome: Feasibility of HMTT as an adjunctive treatment for MDD in adults is considered a composite outcome which will be measured by: • the ability to meet recruitment targets (measured by recruitment logs, comparing actual recruitment against projected targets) • participant retention and completion rates (measured by recruitment logs, attrition rates and completeness of data) • adherence to intended protocol (measured by completion of intervention as planned, missed appointme ....
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Outcome: Safety of HMTT as an adjunctive treatment for MDD in adults will be measured by assessment of adverse events/reactions which will be collected through direct observations by the study nurse during administration of the intervention, and by participant report during the intervention and each visit thereafter
Timepoint: adverse events/reactions will be measured at weeks 0, 2, 4, 6, 8 and 26

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?

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au