Abstract

Background: A growing body of research has shown that consumption of probiotics can improve symptoms associated with mood and anxiety disorders through activity of the gut-brain axis. However, the effects of probiotics have yet to be tested in a clinical sample of treatment-naïve patients diagnosed with Major Depressive Disorder (MDD). The aim of this 8-week, open-label pilot study is to examine changes in depressive symptoms before and after the introduction of a probiotic supplement in 10 treatment-naïve MDD patients and to provide data on the feasibility of conducting a larger double-blind, randomized, placebo-controlled trial in the same patient population. Here we report on the clinical outcome measures of the study.Methods: Participants recruited from the community in Kingston, Ontario, Canada consumed a probiotic supplement containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (CEREBIOME®) at a dose of 3 × 109 CFU once per day for 8 weeks. Clinical symptoms of depression were measured using a validated battery of clinical scales and self-report questionnaires (CAN-BIND protocol). Data was collected at baseline, week 4, and week 8.Results: Significant improvements in affective clinical symptoms were observed at week 4 and were sustained at week 8. Significant improvements in subjective sleep quality were observed by week 8. No side effects or adverse effects associated with the probiotic supplement were observed.Conclusions: The findings from this study support the existing evidence in this emerging field for probiotics having a role in alleviating symptoms of depression in treatment-naïve, moderately depressed patients and indicate that the probiotic supplement is safe and well-tolerated in this population. However, further comprehensive studies are required to draw conclusions.

Highlights

  • Recent advances in gut-brain axis research have linked psychiatric disorders such as depression to changes in the microbiome of the gastrointestinal (GI) tract [1]

  • Probiotics can be obtained through consumption of naturally fermented foods, functional foods that are fortified in such bacteria, or in supplement form

  • A wealth of preclinical data has shown that probiotic consumption improved depression- and anxiety-like behavior in rodent models [4,5,6] and have posited inflammatory activity through the gut-brain axis as driving these effects

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Summary

Introduction

Recent advances in gut-brain axis research have linked psychiatric disorders such as depression to changes in the microbiome of the gastrointestinal (GI) tract [1]. A wealth of preclinical data has shown that probiotic consumption improved depression- and anxiety-like behavior in rodent models [4,5,6] and have posited inflammatory activity through the gut-brain axis as driving these effects. A growing body of research has shown that consumption of probiotics can improve symptoms associated with mood and anxiety disorders through activity of the gut-brain axis. The effects of probiotics have yet to be tested in a clinical sample of treatment-naïve patients diagnosed with Major Depressive Disorder (MDD) The aim of this 8-week, open-label pilot study is to examine changes in depressive symptoms before and after the introduction of a probiotic supplement in 10 treatment-naïve MDD patients and to provide data on the feasibility of conducting a larger double-blind, randomized, placebo-controlled trial in the same patient population. We report on the clinical outcome measures of the study

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