Dataset Information

A randomized controlled trial to examine the impact of a multi-strain probiotic on self-reported indicators of depression, anxiety, mood, and associated biomarkers.

ABSTRACT:

Objective

To examine the efficacy of supplementing with a multi-strain probiotic (MSP) on changes associated with mood, anxiety, and neurotransmitter levels.

Method

In a randomized, double-blind, placebo-controlled fashion, 70 healthy men and women (31.0 ± 9.5 years, 173.0 ± 10.4 cm, 73.9 ± 13.8 kg, 24.6 ± 3.5 kg/m²) supplemented with a single capsule of MSP (a total daily dose of 4 × 10⁹ colony forming units [CFU] comprised of a 1 × 10⁹ CFU dose from each of the following strains: Limosilactobacillus fermentum LF16, Lacticaseibacillus rhamnosus LR06, Lactiplantibacillus plantarum LP01, and Bifidobacterium longum 04, Probiotical S.p.A., Novara, Italy) or a maltodextrin placebo (PLA). After 0, 2, 4, and 6 weeks of supplementation and 3 weeks after ceasing supplementation, study participants completed the Beck Depression Inventory (BDI-II), State-Trait Anxiety Inventory (STAI), and Leiden Index of Depression Sensitivity (LEIDS-R) questionnaires and had plasma concentrations of cortisol, dopamine, serotonin, and C-reactive protein determined.

Results

BDI, STAI, and total LEIDS-R scores were reduced from baseline (p < 0.05) with MSP supplementation after 4 and 6 weeks of supplementation and 3 weeks after supplementation while no changes (p > 0.05) were reported in PLA. When compared to PLA, MSP scores for state anxiety, trait anxiety, and LEIDS-R (hopeless, aggression, rumination, and total score) were significantly lower (p < 0.05) after supplementation. Plasma serotonin concentrations in MSP were increased from baseline after 6 weeks of supplementation and 3 weeks after ceasing supplementation. No changes (p > 0.05) in plasma dopamine, C-reactive protein, or cortisol concentrations were observed between groups.

Conclusion

MSP supplementation resulted in widespread improvements in several questionnaires evaluating mood, anxiety, and depression in young, healthy men and women. MSP supplementation increased serotonin increased after 6 weeks of MSP supplementation with no change in dopamine, C-reactive protein, or cortisol.

Clinical trial registration

https://classic.clinicaltrials.gov/ct2/show/NCT05343533, NCT05343533.

SUBMITTER: Walden KE

PROVIDER: S-EPMC10501394 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

A randomized controlled trial to examine the impact of a multi-strain probiotic on self-reported indicators of depression, anxiety, mood, and associated biomarkers.

Walden Kylie E KE Moon Jessica M JM Hagele Anthony M AM Allen Leah E LE Gaige Connor J CJ Krieger Joesi M JM Jäger Ralf R Mumford Petey W PW Pane Marco M Kerksick Chad M CM

Frontiers in nutrition 20230831

<h4>Objective</h4>To examine the efficacy of supplementing with a multi-strain probiotic (MSP) on changes associated with mood, anxiety, and neurotransmitter levels.<h4>Method</h4>In a randomized, double-blind, placebo-controlled fashion, 70 healthy men and women (31.0 ± 9.5 years, 173.0 ± 10.4 cm, 73.9 ± 13.8 kg, 24.6 ± 3.5 kg/m<sup>2</sup>) supplemented with a single capsule of MSP (a total daily dose of 4 × 10<sup>9</sup> colony forming units [CFU] comprised of a 1 × 10<sup>9</sup> CFU dose f ...[more]

PMID: 37720373

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Project description:Aims The aim of this proof-of-concept study was to understand the effect of daily intake of a 14-strain probiotic on mood, reward learning and emotional and cognitive processing in adults with low mood in the absence of prescribed medication. Salivary cortisol was measured as a marker for physiological stress. Methods In this parallel-group double-blind, placebo-controlled trial, 80 healthy adults with self-identified low mood were randomised to receive either the 14-strain probiotic or placebo for a duration of 4 weeks. Data were collected from participants at baseline (week 0) and post-intervention (week 4). Results Probiotic intake significantly reduced depression scores (by 50%) compared to baseline, as measured by the Patient Health Questionnaire-9 (PHQ-9) scale (p < 0.05). Analysis of individual items in the PHQ-9 revealed that participants taking probiotics reported improved concentration relative to baseline (+ 51%, p < 0.05) and felt less tired compared to placebo (−21%, p < 0.01). Regarding emotional processing, the probiotic group was more accurate at recognising facial expressions compared to those receiving placebo (facial emotion recognition test, +12%, p < 0.05). Furthermore, the probiotic group performed less well at the reward learning task relative to the placebo group (probabilistic instrumental learning task, p < 0.05) and was less vigilant to emotional cues compared neutral cues (dot-probe unmasked test, −8%, P < 0.05). The probiotic group also showed increased susceptibility to emotional interference during a cognitive learning task, relative to placebo (auditory visual learning task, −18% p < 0.05). The study also revealed a downward trend in salivary cortisol in the probiotic group over 4 weeks. Together, these results suggest that probiotics may work via a different psychological mechanism to that of conventional antidepressants. In other words, probiotics may work by reducing emotional salience across all emotions whereas conventional antidepressants are thought to work by increasing bias to positive emotional cues and decreasing bias to negative ones. Conclusion These data suggest that intake of Bio-Kult® Advanced has an effect on mood and that this is achieved in ways distinct from the effects of pharmacological antidepressants. While more research is needed, these results suggest that certain probiotics could form part of an ‘early intervention’ strategy for people experiencing low mood. A second randomised controlled trial (currently recruiting) will provide data on this intervention in patients with a formal diagnosis of depression undergoing concurrent pharmacological treatment. ClinicalTrials.gov Identifier: NCT03801655

Project description:BackgroundIntestinal microbial composition not only affects the health of the gut but also influences centrally mediated systems involved in mood, through the "gut-brain" axis, a bidirectional communication between gut microbiota and the brain. In this context, the modulation of intestinal microbiota and its metabolites through the administration of probiotics seems to represent a very promising approach in the treatment of the central nervous system alterations. Early postnatal life is a critical period during which the brain undergoes profound and essential modulations in terms of maturation and plasticity. Maternal separation (MS), i.e., the disruption of the mother-pup interaction, represents a pivotal paradigm in the study of stress-related mood disorders, by inducing persistent changes in the immune system, inflammatory processes, and emotional behavior in adult mammals.ResultsWe conducted experiments to investigate whether sustained consumption of a multi-strain probiotic formulation by adult male mice could mitigate the effects of maternal separation. Our data demonstrated that the treatment with probiotics was able to totally reverse the anxiety- and depressive-like behavior; normalize the neuro-inflammatory state, by restoring the resting state of microglia; and finally induce a proneurogenic effect. Mice subjected to maternal separation showed changes in microbiota composition compared to the control group that resulted in permissive colonization by the administered multi-strain probiotic product. As a consequence, the probiotic treatment also significantly affected the production of SCFA and in particular the level of butyrate.ConclusionGut microbiota and its metabolites mediate the therapeutic action of the probiotic mix on MS-induced brain dysfunctions. Our findings extend the knowledge on the use of probiotics as a therapeutic tool in the presence of alterations of the emotional sphere that significantly impact on gut microbiota composition. Video Abstract.

Project description:BackgroundMood disorders are dynamic disorders characterized by multimodal symptoms. Clinical assessment of symptoms is currently limited to relatively sparse, routine clinic visits, requiring retrospective recollection of symptoms present in the weeks preceding the visit. Novel advances in mobile tools now support ecological momentary assessment of mood, conducted frequently using mobile devices, outside the clinical setting. Such mood assessment may help circumvent problems associated with infrequent reporting and better characterize the dynamic presentation of mood symptoms, informing the delivery of novel treatment options.ObjectivesThe aim of our study was to validate the Immediate Mood Scaler (IMS), a newly developed, iPad-deliverable 22-item self-report tool designed to capture current mood states.MethodsA total of 110 individuals completed standardized questionnaires (Patient Health Questionnaire, 9-item [PHQ-9]; generalized anxiety disorder, 7-Item [GAD-7]; and rumination scale) and IMS at baseline. Of the total, 56 completed at least one additional session of IMS, and 17 completed one additional administration of PHQ-9 and GAD-7. We conducted exploratory Principal Axis Factor Analysis to assess dimensionality of IMS, and computed zero-order correlations to investigate associations between IMS and standardized scales. Linear Mixed Model (LMM) was used to assess IMS stability across time and to test predictability of PHQ-9 and GAD-7 score by IMS.ResultsStrong correlations were found between standard mood scales and the IMS at baseline (r=.57-.59, P<.001). A factor analysis revealed a 12-item IMS ("IMS-12") with two factors: a "depression" factor and an "anxiety" factor. IMS-12 depression subscale was more strongly correlated with PHQ-9 than with GAD-7 (z=1.88, P=.03), but the reverse pattern was not found for IMS-12 anxiety subscale. IMS-12 showed less stability over time compared with PHQ-9 and GAD-7 (.65 vs .91), potentially reflecting more sensitivity to mood dynamics. In addition, IMS-12 ratings indicated that individuals with mild to moderate depression had greater mood fluctuations compared with individuals with severe depression (.42 vs .79; P=.04). Finally, IMS-12 significantly contributed to the prediction of subsequent PHQ-9 (beta=1.03, P=.02) and GAD-7 scores (beta =.93, P=.01).ConclusionsCollectively, these data suggest that the 12-item IMS (IMS-12) is a valid tool to assess momentary mood symptoms related to anxiety and depression. Although IMS-12 shows good correlation with standardized scales, it further captures mood fluctuations better and significantly adds to the prediction of the scales. Results are discussed in the context of providing continuous symptom quantification that may inform novel treatment options and support personalized treatment plans.

Project description:BackgroundPediatric anxiety and depression are prevalent, impairing, and highly comorbid. Available evidence-based treatments have an average response rate of 60%. One path to increasing response may be to identify likely non-responders midway through treatment to adjust course prior to completing an episode of care. The aims of this study, thus, were to identify predictors of post-intervention response assessing (a) mid-treatment symptom severity, (b) session-by-session treatment process factors, and (c) a model optimizing the combination of these.MethodData were drawn from the treatment arm (N = 95, ages 8-16) of a randomized transdiagnostic intervention trial (Msessions = 11.2). Mid-point measures of youth- and parent-reported anxiety and depression were collected, and therapists rated homework completion, youth and parent engagement, and youth therapeutic alliance at each session. Logistic regression was used to predict response on the Clinical Global Impression Improvement Scale (CGI-I ≤2) rated by independent evaluators masked to treatment condition.ResultsMid-point symptom measures were significant predictors of treatment response, as were therapist-ratings of youth and parent engagement, therapeutic alliance, and homework completion. Therapist ratings were significant when tested as mean ratings summing across the first eight sessions of treatment (all ps < .004) and at individual session points (all ps <0.05). A combined prediction model included youth-reported anxiety, parent-reported depression, youth engagement at Session 2, and parent engagement at Session 8. This model correctly classified 76.5% of youth as non-responders and 91.3% as responders at post-treatment (Nagelkerke R2 = .59, χ2 (4, 80) = 46.54, p < .001).ConclusionThis study provides initial evidence that response to transdiagnostic intervention for pediatric anxiety and depression may be reliably predicted by mid-point. These data may serve as foundational evidence to develop adaptive treatment strategies to personalize intervention, correct treatment course, and optimize outcomes for youth with anxiety and depression.

Project description:IntroductionDepression and anxiety are pervasive mental health disorders with substantial global burdens. Probiotics, live microorganisms known for their health benefits, have emerged as a potential therapeutic intervention for these conditions. This systematic review and meta-analysis aim to evaluate the strain-specific effects of probiotics on relieving depressive and anxiety symptoms while elucidating underlying mechanisms.MethodsEMBASE, Cochrane CENTRAL and PubMed/Medline were systematically queried to identify studies released until May 15, 2024. Randomized Controlled Trials (RCTs) that employed standardized assessment tools for depression and anxiety namely Beck Depression Inventory (BDI), Hamilton Depression Rating Scale (HAMD), Depression Anxiety Stress Scales (DASS), or Montgomery-Asberg Depression Rating Scale (MADRS) were included.Results12 RCTs involving 707 participants were included. Seven RCTs utilizing the BDI questionnaire demonstrated a significant decrease in depressive symptoms favoring probiotics containing strains such as Lactobacillus acidophilus, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus salivarius, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium breve, and Bifidobacterium longum (MD: -2.69, CI95%: -4.22/-1.16, p value: 0.00). Conversely, RCTs using HAMD showed a non-significant reduction in depressive symptoms (MD: -1.40, CI95%: -3.29/0.48, p value: 0.14). RCTs employing DASS and MADRS scales also showed no significant differences.ConclusionThis meta-analysis offers valuable insights into the strain-specific effects of probiotics containing Lactobacillus and Bifidobacterium species on depressive and anxiety symptoms. While our findings suggest a significant reduction in depressive symptoms based on the BDI scale favoring probiotics, the lack of significant effects observed on the HAMD, DASS, and MADRS scales underscores the complexity inherent in these conditions. It is imperative to acknowledge the mixed results across different measurement scales, indicating the need for cautious interpretation. Therefore, we advocate for a nuanced understanding of probiotics' impacts on various dimensions of mood, emphasizing the necessity for further research.

Dataset Information

A randomized controlled trial to examine the impact of a multi-strain probiotic on self-reported indicators of depression, anxiety, mood, and associated biomarkers.

Objective

Method

Results

Conclusion

Clinical trial registration

Publications

A randomized controlled trial to examine the impact of a multi-strain probiotic on self-reported indicators of depression, anxiety, mood, and associated biomarkers.

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