Evidence map›Paper›PMID 35060914›Full record

ArticleInteractive journal of medical research2022

Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study.

Arthi Chinna Meyyappan, Evan Forth, Roumen Milev

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Interactive journal of medical research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04052451 (The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04052451 phase1completednot on this map

The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder

TypeinterventionalSponsorNuBiyotaRan2019 to 2020Enrolled21ConditionsDepression, AnxietyArmsMET-2
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

Arthi Chinna MeyyappanDepartment of Psychiatry, Queen's University, Kingston, ON, Canada.ORCID https://orcid.org/0000-0003-3424-4196
Evan ForthDepartment of Psychiatry, Queen's University, Kingston, ON, Canada.ORCID https://orcid.org/0000-0002-4284-0249
Roumen MilevDepartment of Psychiatry, Queen's University, Kingston, ON, Canada.ORCID https://orcid.org/0000-0001-6884-171X
Providence Health Care · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecent studies have investigated the potential of treatments that modify the gut microbiome, such as fecal microbiota transplantation and probiotics, in individuals with psychiatric illnesses.

objectiveThe 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.

methodsIn 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.

resultsThe 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

conclusionsThe 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 registrationClinicalTrials.gov NCT04052451; https://www.clinicaltrials.gov/ct2/show/NCT04052451. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/17223.

Indexed as

anxietydepressiongut-brain axisMicrobial Ecosystem Therapeuticmicrobiome

Identifiers

PMID35060914
PMCPMC8817211
OpenAlexW4206125469

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.