Safety and feasibility of faecal microbiota transplant for major depressive disorder: study protocol for a pilot randomised controlled trial

Pilot and Feasibility Studies

Study Protocol

Christopher Hair¹  David Castle²  Andrew A. Nierenberg³  Mohammadreza Mohebbi⁴  Amelia J. McGuinness⁴  Amy Loughman⁴  Eugene Athan⁵  Felice Jacka⁶  Michael Berk⁷  Jessica E. Green⁸  John F. Cryan⁹  Philip Strandwitz^1,10 

[1] Barwon Health, Geelong, Australia;Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Toronto, Canada;Dauten Family Center for Bipolar Treatment Innovation, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA;Harvard Medical School, Boston, MA, USA;Deakin University, Food & Mood Centre, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia;Deakin University, Food & Mood Centre, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia;Barwon Health, Geelong, Australia;School of Medicine, Deakin University, Geelong, Australia;Deakin University, Food & Mood Centre, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia;Centre for Adolescent Health, Murdoch Children’s Research Institute, Royal Children’s Hospital, Parkville, Australia;Black Dog Institute, Melbourne, Australia;James Cook University, Townsville, Australia;Deakin University, Food & Mood Centre, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia;Department of Psychiatry, University of Melbourne, Parkville, Australia;Orygen Youth Health Research Centre and the Centre of Youth Mental Health, Melbourne, Australia;The Florey Institute for Neuroscience and Mental Health, Parkville, Australia;Barwon Health, Geelong, Australia;Deakin University, Food & Mood Centre, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia;Monash Alfred Psychiatry Research Centre (MAPrc), Central Clinical School, Faculty of Medicine Nursing and Health Sciences, Monash University, Melbourne, Australia;Department of Psychiatry, Peninsula Health, Frankston, Australia;Department of Anatomy and Neuroscience, University College Cork and APC Microbiome, Cork, Ireland;Holobiome, Inc., Boston, MA, USA;

关键词: Faecal microbiota transplantation;    Microbiome;    RCT;    Psychiatry;    Mental disorder;    Neuroscience;    Depression;    Major depressive disorder;    Mood disorders;    Mental health;   

DOI  :  10.1186/s40814-023-01235-z

 received in 2022-05-29, accepted in 2023-01-02,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundMental disorders, including major depressive disorder (MDD), are a leading cause of non-fatal burden of disease globally. Current conventional treatments for depression have significant limitations, and there have been few new treatments in decades. The microbiota-gut-brain-axis is now recognised as playing a role in mental and brain health, and promising preclinical and clinical data suggest Faecal Microbiota Transplants (FMT) may be efficacious for treating a range of mental illnesses. However, there are no existing published studies in humans evaluating the efficacy of FMT for MDD.Methods and designThis protocol describes an 8-week, triple-blind, 2:1 parallel group, randomised controlled pilot trial (n = 15), of enema-delivered FMT treatment (n = 10) compared with a placebo enema (n = 5) in adults with moderate-to-severe MDD. There will be a further 26-week follow-up to monitor longer-term safety. Participants will receive four FMT or placebo enemas over four consecutive days. The primary aims of the study are to evaluate feasibility and safety of FMT as an adjunctive treatment for MDD in adults. Changes in gut microbiota will be assessed as a secondary outcome. Other data will be collected, including changes in depression and anxiety symptoms, and safety parameters.DiscussionModification of the microbiota-gut-brain axis via FMT is a promising potential treatment for MDD, but there are no published rigorous clinical trials evaluating its use. If this study finds that our FMT strategy is safe and feasible, a larger fully powered RCT is planned. Further high-quality research in this field is urgently needed to address unmet need.Trial registrationAustralian and New Zealand Clinical Trials Registry: ACTRN12621000932864

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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