None listed
Conditions
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.
Interventions
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 obsersva
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 obsersvation by study nurse will ensure adherence to the intervention.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
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) • Comorbid psychiatric disturbances including bipolar disorder, a primary psychotic illness, obsessive-compulsive disorder, anorexia nervosa or bulimia nervosa • Active substance-use disorder, defined as a score of 6 or greater on the brief Drug Abuse Screening Test (DAST-10), and/or a score of 16 or greater in the Alcohol Use Disorders Identification Test (AUDIT) • Inability to read and understand the participant information and informed consent form • Patients with a history of severe anaphylactic or anaphylactoid food allergy • A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study
Outcome results
None listed