The efficacy, safety, and tolerability of probiotics on depression: clinical results from an open-label pilot study

Current evidence points to the positive impact of probiotics on improving mood and anxiety symptoms via influencing the gut-brain axis. However, the impact of probiotics on Major Depressive Disorder (MDD) patients who are not on treatment is unknown. In this open-label pilot study by Wallace & Milev (2021), the authors investigated the impact of probiotic supplements on 10 treatment-naïve MDD patients for a period of eight weeks, evaluating symptoms of depression before and after the probiotic intervention, with the aim to produce a volume of preliminary data in order to facilitate conducting a more prudent double-blind, randomized, placebo-controlled trial. The participants hailed from the same local community, and were given a probiotic supplement composed of Bifidobacterium longum R0175 and Lactobacillus helveticus R0052 (3 × 109 CFU once/day for eight weeks – CEREBIOME®). Depression was evaluated using the CAN-BIND protocol of self-reported questionnaires and clinical scales. Data for the study was collected at three timepoints: initiation, fourth week and at completion (eighth week). Analysis of the data revealed that participants experienced a substantial amelioration of symptoms of depression by the fourth week, which carried forward to the eighth week. In particular, the participants experienced a substantial enhancement in sleep quality by the eighth week, with no reported adverse effects from using the probiotic supplement. The authors conclude that their study corroborates current findings on the impact of probiotics in improving depressive symptoms in treatment-naïve MDD patients, and that these supplements are safe for use. Finally, the authors comment that more research is necessary in order to develop treatment guidelines. [NPID: Probiotics, Major Depressive Disorder, pilot study]

Year: 2021

Reference: Wallace, C., & Milev, R. V. (2021). The Efficacy, Safety, and Tolerability of Probiotics on Depression: Clinical Results From an Open-Label Pilot Study. Frontiers in psychiatry, 12, 618279. https://doi.org/10.3389/fpsyt.2021.618279