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Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study.
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: 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). 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.
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Systematic review of probiotics as an adjuvant treatment for psychiatric disorders.
INTRODUCTION: Many psychiatric illnesses have been linked to the gut microbiome, with supplements such as probiotics showing some efficacy in alleviating the symptoms of some psychiatric illnesses. The aim of this review is to evaluate the current literature investigating the effects of adjuvant probiotic or synbiotic administration in combination with first-line treatments for psychiatric illnesses. METHOD: A systematic search of four databases was conducted using key terms related to treatments for psychiatric illnesses, the gut microbiome, and probiotics. All results were then evaluated based on specific eligibility criteria. RESULTS: Eight studies met eligibility criteria and were analyzed for reported changes in outcome measures used to assess the symptoms of psychiatric illness and the tolerability of treatment. All Major Depressive Disorder (MDD) (n = 5) and Generalized Anxiety Disorder (GAD) (n = 1) studies found adjuvant probiotic or synbiotic treatment to be more efficacious in improving the symptoms of psychiatric illness than the first-line treatment alone or with placebo. The schizophrenia studies (n = 2) found adjuvant probiotic treatment to have no significant difference in clinical outcomes, but it was found to improve the tolerability of first-line antipsychotics. DISCUSSION AND CONCLUSION: The findings of the studies included in this review suggest the use of adjuvant probiotic treatment with selective serotonin reuptake inhibitors (SSRIs) for MDD and GAD to be superior to SSRI treatment alone. Probiotic adjuvant treatment with antipsychotics could be beneficial for improving the tolerability of the antipsychotics, but these findings do not suggest that adjuvant probiotic treatment would result in improved clinical outcomes for symptoms of schizophrenia.
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Probiotics for Anxiety and Depressive Symptoms in Cancer: A Systematic Review of Animal and Human Studies with Mechanistic Insights.
Probiotics have been increasingly evaluated for their potential effect on anxiety and depression through the modulation of the gut-brain axis. Individuals with cancer experience a high prevalence of these symptoms. However, the effects of probiotics and their underlying mechanisms in this population have not been systematically evaluated. This review synthesizes current evidence regarding probiotic interventions for anxiety and depression in cancer and examines the associated mechanistic pathways. A systematic search for original trials in PubMed, Embase, CINAHL, Web of Science, and PsycINFO was conducted in May 2025. Eligible studies included animal models or adults with cancer who received probiotics alone or in combination with other treatments, with outcomes related to anxiety, depressive symptoms, or depression. Search terms included animal model, cancer, probiotics, anxiety, depressive symptoms, depression, gastrointestinal microbiome, gut microbiome, and microbiota. The review followed PRISMA guidelines. Risk of bias in trials was assessed using the SYRCLE and Cochrane RoB2 tool. Nine studies met the inclusion criteria, including seven human studies, one animal study, and one mixed human-animal study, with human sample sizes ranging from 24 to 266. The animal study reported reductions in depressive and anxiety-like behaviors, paralleled by modulation of the hypothalamic-pituitary-adrenal (HPA) axis, reduced inflammation, rebalancing of the gut microbiota, and improvements in neurotransmitter pathways. Findings from human studies were more variable. Some trials reported improvements in anxiety, and depressive symptoms, while others showed no significant differences compared with control groups. Studies that combined probiotics with antidepressants or exercise demonstrated the most pronounced reductions in anxiety and depression. Mechanistic insights from human studies partially aligned with animal evidence, with several trials showing reductions in inflammatory markers (IL-6, TNF-α), improvements in neuroendocrine measures (serotonin, dopamine, cortisol), stabilization of metabolic markers, and favorable shifts in gut microbiota, although these effects were not consistent across all studies. Probiotics appear to be safe within the intervention periods of the reviewed studies (<24 weeks), as no serious adverse effects were reported. Substantial heterogeneity across studies, including variations in cancer type, intervention duration, probiotic strains, formulations, dosages, and study design combined with small sample sizes, restricts the ability to draw definitive conclusions. Rigorously designed randomized controlled trials with larger sample sizes and mechanistic biomarkers are required to confirm the efficacy of probiotics for relieving anxiety and depression in the cancer population.
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[Research progress in the bidirectional relationship between oral infectious diseases and mental health issues].
Infectious oral diseases represent the most prevalent categories of oral conditions, including dental caries, periodontitis, periapical lesions, and pericoronitis. Their bidirectional relationship with mental health has emerged as a critical interdisciplinary research frontier. This paper integrates epidemiological findings and molecular mechanism evidence to analyze the significant comorbidity and correlation characteristics between infectious oral diseases such as caries and periodontitis, and psychological disorders including depression and anxiety. Oral diseases not only directly impair mental well-being through pain, functional impairment, and social anxiety, but also induce systemic inflammatory responses that disrupt the blood-brain barrier, activate microglia, and alter neurotransmitter metabolism, thereby contributing to functional dysregulation within emotional regulatory centers. The dysbiosis of the oral microbiota caused by infectious oral diseases plays a central role in the vicious cycle of "oral infection-mental health disorders" through the"oral-gut-brain axis", inflammation-mediated neuroimmune cascades, and hypothalamic-pituitary-adrenal axis dysregulation. Meanwhile, mental disorders exacerbate oral microbial imbalance and tissue destruction through poor oral hygiene behaviors, xerostomia induced by psychotropic medications, and stress-related neuroendocrine alterations. This paper advocates for synergistically integrate oral clinical interventions with mental health improvement strategies, and for the development of microbiome-targeted precision modulation approaches. It further proposes an integrated health management paradigm that bridges dentistry and psychiatry, providing both theoretical foundations and practical pathways to transcend traditional disciplinary boundaries and achieve holistic oral-mental co-management.
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Intolerance of uncertainty and mental health in patients with IBD: the mediating role of maladaptive coping.
The aim of this study was to investigate the relationship between intolerance of uncertainty (IU) and mental health in patients with Inflammatory Bowel Disease (IBD), and to explore the mediating role of coping styles. A questionnaire was administered to adult patients with IBD, which included general demographic information, the Intolerance of Uncertainty Scale, the Generalized Anxiety Disorder-7, and the Patient Health Questionnaire-9. The study ultimately included validated questionnaires from 163 IBD patients. Intolerance of uncertainty was significantly and positively correlated with anxiety (r = 0.738, p < 0.01) and depression (r = 0.683, p < 0.01). The mediating effect of adaptive coping style was not significant. The maladaptive coping style partially mediated the relationship between IU and anxiety, as well as between IU and depression, with the mediating effect size of 25.5% and 34.2%, respectively. Our findings emphasize the impact of the inability to tolerate uncertainty on the mental health of patients with IBD. It suggests that interventions can be implemented to enhance IBD patients' tolerance of uncertainty and to modify their maladaptive coping styles to promote mental health. This offers a valuable framework for psychological interventions for IBD patients.
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Gut Microbiota in Psychiatric and Neurological Disorders: Current Insights and Therapeutic Implications.
Recent studies increasingly highlight the complex interaction between gut microbiota and mental health, drawing attention to the role of the microbiota-gut-brain axis (MGBA) in the pathophysiology of mental and neurodevelopmental disorders. Changes in the composition of the gut microbiota-dysbiosis-are associated with conditions such as depression, schizophrenia, bipolar disorder (BD), autism spectrum disorders (ASD), attention deficit hyperactivity disorder (ADHD), and neurodegenerative diseases such as Parkinson's and Alzheimer's. These microbial imbalances can affect brain function through a variety of mechanisms, including activation of the immune system, alteration of intestinal permeability, modulation of the digestive and central nervous systems, and changes in the production of neuroactive metabolites such as short-chain fatty acids, serotonin, and tryptophan derivatives. The aim of this paper is to review the current state of knowledge on therapeutic strategies targeting the gut microbiome-including probiotics, prebiotics, synbiotics, personalized dietary interventions, and fecal microbiota transplantation (FMT)-which are becoming promising adjuncts or alternatives to conventional psychopharmacology, offering a forward-looking and individualized approach to mental health treatment. Understanding the bidirectional and multifactorial nature of MGBA may pave the way for new, integrative treatment paradigms in psychiatry and neurology, requiring further research and exploration of their scope of application.
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Identifying a biological signature of prenatal maternal stress.
Psychological stress affects maternal gastrointestinal (GI) permeability, leading to low-grade inflammation, which can negatively affect fetal development. We investigated a panel of circulating markers as a biological signature of this stress exposure in pregnant women with and without the stress-related GI disorder irritable bowel syndrome (IBS). Markers of GI permeability and inflammation were measured in plasma from healthy and IBS cohorts of women at 15 and 20 weeks' gestation. Biomarkers were evaluated with respect to their degree of association to levels of stress, anxiety, and depression as indicated by responses from the Perceived Stress Scale, State-Trait Anxiety Inventory, and Edinburgh Postnatal Depression Scale. High levels of stress were associated with elevations of soluble CD14, lipopolysaccharide binding protein (LBP), and tumor necrosis factor-α, while anxiety was associated with elevated concentrations of C-reactive protein (CRP) in otherwise healthy pregnancies. Prenatal depression was associated with higher levels of soluble CD14, LBP, and CRP in the healthy cohort. High levels of prenatal anxiety and depression were also associated with lower concentrations of tryptophan and kynurenine, respectively, in the IBS cohort. These markers may represent a core maternal biological signature of active prenatal stress, which can be used to inform intervention strategies via stress reduction techniques or other lifestyle approaches. Such interventions may need to be tailored to reflect underlying GI conditions, such as IBS.
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Exploratory characterization of gut microbiota and cognitive profiles in adolescents with subthreshold depression: a shotgun metagenomics sequencing study.
Subthreshold depression (SD) in adolescents is a prevalent condition associated with significant functional impairment and an increased risk of developing major depressive disorder. Currently, the lack of reliable objective markers complicates its accurate identification. Investigating the gut microbiome may offer novel insights into its underlying mechanisms. This study aimed to investigate the association between gut microbiome and cognitive function in adolescents with subthreshold Depression (SD). Thirty-eight adolescents with SD and 139 clinically-well (CW) adolescents were recruited. Gut microbiome and cognitive function were assessed by metagenomic sequencing and the MATRICS Consensus Cognitive Battery (MCCB), respectively. Compared with the CW adolescents, the SD group showed higher relative abundance of Spirochaetes, Synergistetes, Spirochaetia, Synergistia, Spirochaetales, Rhizobiales, Synergistales, Thermoanaerobacterales, Rhodospirillales, Synergistaceae, and Oxalobacteraceae at four levels. The Spatial Span scores were higher in the SD group compared to the CW group. Moreover, EggNOG analyses showed a significant negative correlation of the intracellular trafficking secretion, and vesicular transport with the Spatial Span scores. The KEGG pathway of the neurodegenerative diseases and translation was depleted in the microbiome of adolescents with SD. The higher abundance of Spirochaetes, Spirochaetia, and Spirochaetales was the best predictor of SD in adolescents. Our findings suggest that gut microbiome abnormalities, depressive symptoms, and cognitive influences co-occur in adolescents with SD, which may play a crucial role in the pathogenesis of SD and cognitive function in adolescent. Gut microbiome may serve as a potential biomarker for the identification and treatment of adolescents with SD.
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The effect of SSRI/SNRI antidepressant treatment on the gut microbiota of patients with major depressive disorder.
BACKGROUND: The gut microbiome has been linked to major depressive disorder (MDD), yet it remains unclear whether antidepressant treatment influences these associations. This study aimed to clarify the role of serotonin reuptake inhibitors (SSRI/SNRI) in shaping gut microbiome changes observed in MDD. METHODS: We conducted cross-sectional analyses in two independent patient cohorts (total N = 1802) and a meta-analysis across both cohorts, comparing the gut microbiome of MDD patients with and without SSRI/SNRI treatment. RESULTS: Here we show that SSRI/SNRI treatment is consistently associated with reduced Clostridium sensu stricto 1 abundance. This effect is specific to SSRI/SNRI treatment and not observed with other psychotropic medications. Importantly, reductions in Clostridium sensu stricto 1 in MDD compared to unaffected controls are explained by SSRI/SNRI medication status. CONCLUSIONS: Antidepressant treatment is an important factor shaping gut microbiome alterations linked to MDD, underscoring the need to account for medication effects and potentially informing future microbiome-based strategies to improve treatment response.
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A bidirectional relationship between anxiety, depression and gastrointestinal symptoms in Parkinson's disease.
INTRODUCTION: Anxiety, depression and gastrointestinal (GI) symptoms are common non-motor symptoms in Parkinson's disease (PD). Past studies provide evidence of a disrupted microbiome-gut-brain axis in PD, which is associated with certain motor and non-motor symptoms in PD. Additionally, there is evidence of a bidirectional association between mental health and gut health among individuals with GI disorders. The current study examined the bidirectional association between GI symptoms and anxiety/depression among individuals newly diagnosed with PD. METHODS: We conducted a secondary data analysis of the Parkinson's Progression Markers Initiative. This included 487 individuals newly diagnosed with PD and followed for up to 5 years. Participants completed questionnaires of anxiety, depression and GI symptoms (Scales for Outcomes in Parkinson's Disease Autonomic; SCOPA-AUT) at each annual visit. Multilevel models examined the bidirectional-lagged relationship between GI symptoms and anxiety/depression. RESULTS: Models provided evidence for a bidirectional relationship between GI symptoms and anxiety/depression. Specifically, more severe GI symptoms predicted more severe anxious/depressive symptoms within the same year and at the following year. There was also evidence of the inverse directionality, meaning that more severe anxiety/depression predicted more severe GI symptoms concurrently and in the following year. DISCUSSION: Findings provide preliminary evidence for a cyclical relationship among gut health and mental health in PD. Future studies are needed to examine if the microbiome-gut-brain axis plays a mechanistic role.