Effects of Probiotic NVP-1704 on Mental Health and Sleep in Healthy Adults: An 8-Week Randomized, Double-Blind, Placebo-Controlled Trial.

Nutrients. 2021;13(8)

Plain language summary

Dietary changes directly alter the gut microbiome composition. A diversified gut microbiome may have therapeutic implications for mental health, and specific strains of probiotics have shown the potential to treat depression and anxiety. Several preclinical trials have found the probiotic mixture NVP-1704 to alleviate depression and anxiety in mice through modulating the gut-brain-microbiome axis. The aim of this randomised, double-blind, placebo-controlled, parallel study was to examine the efficacy and safety of NVP-1704 for the management of depression, anxiety and insomnia in healthy adults. A total of 156 healthy adults with subclinical depression, anxiety and insomnia were randomised to receive either NVP-1704 or placebo for eight weeks. Participants completed various questionnaires and biomarkers of stress and inflammation were assessed. After eight weeks, this study found that NVP-1704 to be a safe and well-tolerated probiotic with beneficial effects on depression, sleep quality, inflammation and gut microbiome composition in healthy adults. Based on this study, the authors conclude the therapeutic effects of NVP-1704 previously found in preclinical mice trials may now be translated to clinical trials. The authors suggest large, highly controlled, longitudinal human studies be conducted in the future to further confirm the benefits of probiotics on mental health and sleep.

Abstract

The human gut microbiome is closely linked to mental health and sleep. We aimed to verify the efficacy and safety of probiotic NVP-1704, a mixture of Lactobacillus reuteri NK33 and Bifidobacterium adolescentis NK98, in improving stress, depression, anxiety, and sleep disturbances, along with the measurement of some blood biomarkers. A total of 156 healthy adults with subclinical symptoms of depression, anxiety, and insomnia were retrospectively registered and randomly assigned to receive either NVP-1704 (n = 78) or a placebo (n = 78) for eight weeks. Participants completed the Stress Response Inventory, Beck's Depression and Anxiety Inventory, Pittsburg Sleep Quality Index, and Insomnia Severity Index at baseline, at four and eight weeks of treatment. Pre- and post-treatment blood tests for biomarkers were conducted. After intervention, gut microbiota composition was quantified by pyrosequencing the bacterial 16S rRNA gene. The NVP-1704 group had a more significant reduction in depressive symptoms at four and eight weeks of treatment, and anxiety symptoms at four weeks compared to the placebo group. Those receiving NVP-1704 also experienced an improvement in sleep quality. NVP-1704 treatment led to a decrease in serum interleukin-6 levels. Furthermore, NVP-1704 increased Bifidobacteriaceae and Lactobacillacea, whereas it decreased Enterobacteriaceae in the gut microbiota composition. Our findings suggest that probiotic NVP-1704 could be beneficial for mental health and sleep.

Lifestyle medicine

Fundamental Clinical Imbalances : Neurological ; Digestive, absorptive and microbiological
Patient Centred Factors : Mediators/Probiotics
Environmental Inputs : Nutrients ; Microorganisms
Personal Lifestyle Factors : Nutrition ; Stress and resilience
Functional Laboratory Testing : Blood ; Stool ; Urine

Methodological quality

Jadad score : 5
Allocation concealment : Yes

Metadata