Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study.
| Autor: | Chinna Meyyappan A; Department of Psychiatry, Queen's University, Kingston, ON, Canada.; Centre for Neuroscience Studies, Queen's University, Kingston, ON, Canada.; Providence Care Hospital, Kingston, ON, Canada., Forth E; Department of Psychiatry, Queen's University, Kingston, ON, Canada.; Centre for Neuroscience Studies, Queen's University, Kingston, ON, Canada.; Providence Care Hospital, Kingston, ON, Canada., Milev R; Department of Psychiatry, Queen's University, Kingston, ON, Canada.; Centre for Neuroscience Studies, Queen's University, Kingston, ON, Canada.; Providence Care Hospital, Kingston, ON, Canada. |
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| Jazyk: | angličtina |
| Zdroj: | Interactive journal of medical research [Interact J Med Res] 2022 Jan 21; Vol. 11 (1), pp. e32234. Date of Electronic Publication: 2022 Jan 21. |
| DOI: | 10.2196/32234 |
| Abstrakt: | Background: Recent studies have investigated the potential of treatments that modify the gut microbiome, such as fecal microbiota transplantation and probiotics, in individuals with psychiatric illnesses. Objective: The aim of this study was to investigate the safety, tolerability, and efficacy of a novel gut microbiome therapeutic, Microbial Ecosystem Therapuetic-2 (MET-2), in people with depression and anxiety. Methods: In this phase 1, open-label trial, 12 adults diagnosed with major depressive disorder, generalized anxiety disorder, or both were recruited. Over 8 weeks, participants consumed three capsules per day, orally, of an encapsulated microbial therapeutic (MET-2), which contained 40 strains of bacteria that were purified and lab-grown from the stool of a single healthy donor. Participants were assessed biweekly using clinical scales and questionnaires in order to evaluate the safety, efficacy, and tolerability of the therapeutic. Results: The therapeutic was found to be generally safe and tolerable, with limited adverse events and side effects and no serious adverse events. Of the 12 individuals included in this study, 9 (75%) responded to treatment (50% improvement in Montgomery-Asberg Depression Rating Scale [MADRS] scores, 7-item Generalized Anxiety Disorder scale [GAD-7] scores, or both, from baseline to the week-8 visit). Over the course of 10 weeks, MET-2 significantly decreased mean MADRS and GAD-7 scores (MADRS: F Conclusions: The findings from this study are the first to provide evidence for the role of microbial ecosystem therapy in treating depression and anxiety. However, a double-blind, randomized controlled trial with a larger sample size is needed for more conclusive results. Trial Registration: ClinicalTrials.gov NCT04052451; https://www.clinicaltrials.gov/ct2/show/NCT04052451. International Registered Report Identifier (irrid): RR2-10.2196/17223. (©Arthi Chinna Meyyappan, Evan Forth, Roumen Milev. Originally published in the Interactive Journal of Medical Research (https://www.i-jmr.org/), 21.01.2022.) |
| Databáze: | MEDLINE |
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