{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T11:03:04Z","timestamp":1785495784903,"version":"3.56.0"},"reference-count":29,"publisher":"JMIR Publications Inc.","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Interact J Med Res"],"abstract":"\n Background<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n 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: F2.731, 30.05=8.784, P<.001; GAD-7: F2.778, 30.55= 9.638, P<.001). Multiple comparisons with Bonferroni adjustments showed a significant reduction in MADRS scores from baseline (mean 19.00, SD 4.843) to week 6 (mean 11.25, SD 8.001; P=.009), week 8 (mean 8.667, SD 8.732; P=.002), and week 10 (mean 8.250, SD 9.304; P=.006). Multiple comparisons showed a significant reduction in GAD-7 scores from baseline (mean 13.58, SD 4.010) to week 4 (mean 9.167, SD 5.096; P=.03), week 6 (mean 7.667, SD 4.539; P=.004), week 8 (mean 7.333, SD 6.583; P=.03), and week 10 (mean 7.500, SD 6.448; P=.03).<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n ClinicalTrials.gov NCT04052451; https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT04052451<\/jats:p>\n <\/jats:sec>\n \n International Registered Report Identifier (IRRID)<\/jats:title>\n RR2-10.2196\/17223<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/32234","type":"journal-article","created":{"date-parts":[[2022,1,21]],"date-time":"2022-01-21T09:00:36Z","timestamp":1642755636000},"page":"e32234","source":"Crossref","is-referenced-by-count":15,"title":["Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study"],"prefix":"10.2196","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3424-4196","authenticated-orcid":false,"given":"Arthi","family":"Chinna 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