Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Bipolar Disorder

Summary

Every human harbors complex microbial communities (collectively, the human 'microbiome') that cover the skin and the body's mucosal surfaces. There is mounting evidence of an interaction between the intestinal microbiota, the gut, and the central nervous system (CNS) in what is recognized as the microbiome-gut-brain axis. Based on this compelling body of evidence, there is growing enthusiasm for work that is focused on translating this emerging association into novel therapies for psychiatric illness. Fecal microbiota transplantation(FMT) is a technique in which gut bacteria are transferred from a healthy screened donor to a patient, with the goal to introduce or restore a stable microbial community in the gut.There are no clinical trials examining the impact of FMT on Bipolar Disorder (BD). However, there is biological rationale to support this type of treatment, given the known inflammatory underpinnings of this illness. The objective of this study is to assess the effectiveness of this very novel therapy targeting the gut-brain axis, FMT, to treat bipolar depression. Study Hypotheses: Main hypothesis: FMT from healthy donors to patients with BD depression will improve depression symptoms as an adjunct to approved medication. Secondary hypotheses: 1. FMT will also reduce anxiety and global function 2. FMT is safe and will be well tolerated by the patients 3. Improvements in clinical parameters will be associated with specific changes in the intestinal microbiome and/or metabolites in stool and serum

Timeline

Start

2018-01-01

Primary completion

2022-03-15

Completion

2022-12-31

Publications

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• Cooke NCA, Bala A, Allard JP, Hota S, Poutanen S, Taylor VH. The safety and efficacy of fecal microbiota transplantation in a population with bipolar disorder during depressive episodes: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Jul 14;7(1):142. doi: 10.1186/s40814-021-00882-4.

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Indications