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Randomized Controlled Trial
. 2017 Aug;51(8):810-821.
doi: 10.1177/0004867416686694. Epub 2017 Jan 10.

A double-blind, randomized, placebo-controlled trial of Lactobacillus helveticus and Bifidobacterium longum for the symptoms of depression

Amy R Romijn  1   2 , Julia J Rucklidge  1 , Roeline G Kuijer  1 , Chris Frampton  3
Affiliations
Randomized Controlled Trial

A double-blind, randomized, placebo-controlled trial of Lactobacillus helveticus and Bifidobacterium longum for the symptoms of depression

Amy R Romijn et al. Aust N Z J Psychiatry. 2017 Aug.

Abstract

Objectives: This trial investigated whether probiotics improved mood, stress and anxiety in a sample selected for low mood. We also tested whether the presence or severity of irritable bowel syndrome symptoms, and levels of proinflammatory cytokines, brain-derived neurotrophic factor and other blood markers, would predict or impact treatment response.

Method: Seventy-nine participants (10 dropouts) not currently taking psychotropic medications with at least moderate scores on self-report mood measures were randomly allocated to receive either a probiotic preparation (containing Lactobacillus helveticus and Bifidobacterium longum) or a matched placebo, in a double-blind trial for 8 weeks. Data were analysed as intent-to-treat.

Results: No significant difference was found between the probiotic and placebo groups on any psychological outcome measure (Cohen's d range = 0.07-0.16) or any blood-based biomarker. At end-point, 9 (23%) of those in the probiotic group showed a ⩾60% change on the Montgomery-Åsberg Depression Rating Scale (responders), compared to 10 (26%) of those in the placebo group ([Formula: see text], p = ns). Baseline vitamin D level was found to moderate treatment effect on several outcome measures. Dry mouth and sleep disruption were reported more frequently in the placebo group.

Conclusions: This study found no evidence that the probiotic formulation is effective in treating low mood, or in moderating the levels of inflammatory and other biomarkers. The lack of observed effect on mood symptoms may be due to the severity, chronicity or treatment resistance of the sample; recruiting an antidepressant-naive sample experiencing mild, acute symptoms of low mood, may well yield a different result. Future studies taking a preventative approach or using probiotics as an adjuvant treatment may also be more effective. Vitamin D levels should be monitored in future studies in the area. The results of this trial are preliminary; future studies in the area should not be discouraged.

Keywords: Probiotic; anxiety; gut; immune function; inflammation; mood; stress; vitamin D.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Romijn has received research funding from Lallemand Health Solutions. None of the other authors have any conflicts of interest to declare.

Figures

Figure 1.
Figure 1.
CONSORT flow diagram.
See this image and copyright information in PMC

References

    1. Akkasheh G, Kashani-Poor Z, Tajabadi-Ebrahimi M, et al. (2016) Clinical and metabolic response to probiotic administration in patients with major depressive disorder: A randomized, double-blind, placebo-controlled trial. Nutrition 32: 315–320. - PubMed
    1. Anglin RE, Samaan Z, Walter SD, et al. (2013) Vitamin D deficiency and depression in adults: Systematic review and meta-analysis. British Journal of Psychiatry 202: 100–107. - PubMed
    1. Arseneault-Breard J, Rondeau I, Gilbert K, et al. (2012) Combination of Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 reduces post-myocardial infarction depression symptoms and restores intestinal permeability in a rat model. British Journal of Nutrition 107: 1793–1799. - PubMed
    1. Ascoli BM, Géa LP, Colombo R, et al. (2016) The role of macrophage polarization on bipolar disorder: Identifying new therapeutic targets. Australian and New Zealand Journal of Psychiatry 0004867416642846. - PubMed
    1. Battersby AJ, Kampmann B, Burl S. (2012) Vitamin D in early childhood and the effect on immunity to Mycobacterium tuberculosis. Clinical and Developmental Immunology 2012: 430972. - PMC - PubMed

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