Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study
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,...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2022-01-01
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| Series: | Interactive Journal of Medical Research |
| Online Access: | https://www.i-jmr.org/2022/1/e32234 |
| _version_ | 1797735400517664768 |
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| author | Arthi Chinna Meyyappan Evan Forth Roumen Milev |
| author_facet | Arthi Chinna Meyyappan Evan Forth Roumen Milev |
| author_sort | Arthi Chinna Meyyappan |
| collection | DOAJ |
| description |
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: 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).
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 |
| first_indexed | 2024-03-12T12:58:30Z |
| format | Article |
| id | doaj.art-75413ce3c77d40b58d0448b6d582fd2f |
| institution | Directory Open Access Journal |
| issn | 1929-073X |
| language | English |
| last_indexed | 2024-03-12T12:58:30Z |
| publishDate | 2022-01-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | Interactive Journal of Medical Research |
| spelling | doaj.art-75413ce3c77d40b58d0448b6d582fd2f2023-08-28T20:24:22ZengJMIR PublicationsInteractive Journal of Medical Research1929-073X2022-01-01111e3223410.2196/32234Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label StudyArthi Chinna Meyyappanhttps://orcid.org/0000-0003-3424-4196Evan Forthhttps://orcid.org/0000-0002-4284-0249Roumen Milevhttps://orcid.org/0000-0001-6884-171X 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: 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). 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)RR2-10.2196/17223https://www.i-jmr.org/2022/1/e32234 |
| spellingShingle | Arthi Chinna Meyyappan Evan Forth Roumen Milev Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study Interactive Journal of Medical Research |
| title | Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study |
| title_full | Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study |
| title_fullStr | Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study |
| title_full_unstemmed | Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study |
| title_short | Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study |
| title_sort | microbial ecosystem therapeutic 2 intervention in people with major depressive disorder and generalized anxiety disorder phase 1 open label study |
| url | https://www.i-jmr.org/2022/1/e32234 |
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