Not available
ACTRN12621000932864
Treatment
Not Applicable
Charities/Societies/Foundations,Wilson Foundation
Dr Jessica Green
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 .... Read more
• 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
• 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 .... Read more
No
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 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 .... Read more
Control group Placebo
identical placebo product comprised of normal saline solution, 10% glycerol and brown dye
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 .... Read more
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
No