Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 27, 2019
Date Accepted: Mar 30, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People with Major Depression and/or Generalized Anxiety Disorder: Protocol for Phase 1, Open Label Study
ABSTRACT
Background:
The bidirectional signalling between the gut microbiota and the brain, known as the gut-brain axis, is being heavily explored in current neuropsychiatric research. Analyses of the human gut microbiota have shown considerable individual variability in bacterial content which is hypothesized to influence brain function, and potentially mood and anxiety symptoms, through gut-brain axis communication. Preclinical and clinical research examining these effects suggests that fecal microbiota transplant (FMT) may aid in improving depression and anxiety symptoms and severity by recolonizing the gastrointestinal tract with healthy bacteria. The microbial ecosystem therapeutic, known as MET-2, used in this study is an alternative treatment to FMT that is composed of 40 different strains of gut bacteria from a healthy donor.
Objective:
The primary objective of this study is to assess subjective changes in mood and anxiety symptoms before, during, and after administration of MET-2. The secondary objectives of this study are to assess changes in metabolic functioning and level of repopulation of healthy gut bacteria, safety and tolerability of therapeutic, and effects of early stress on biomarkers of depression/anxiety and response to treatment.
Methods:
Adults experiencing depressive or anxiety symtpoms will be recruited from the Kingston area. These participants will orally consume once daily an encapsulated microbial therapeutic, containing 40 strains of bacteria purified and lab-grown from a single healthy donor, for 8 weeks, followed by a two-week treatment-free follow-up period. Participants undergo a series of clinical assessments measuring mood, anxiety, and GI symptoms using validated clinical scales and questionnaires. Molecular data will be collected from blood and fecal samples to assess metabolic changes, neurotransmitter levels, inflammatory markers, and level of engraftment for fecal samples that may predict outcomes in depression or anxiety.
Results:
Given the association between gut bacteria and risk factors of depression, we expect to observe an improvement in depressive and anxiety symptoms and severity following treatment, and that this improvement is mediated by the recolonization of the gastrointestinal tract with healthy bacteria.
Conclusions:
The findings of this study may be the first to provide evidence for the role of microbial therapy in treating depression and anxiety. Clinical Trial: Clinicaltrials.gov, NCT04052451. Registered 9 August 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04052451
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Copyright
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