Probiotics as a treatment for prenatal maternal anxiety and depression: a double-blind randomized pilot trial.

Affiliation

Browne PD(1)(2), Bolte AC(3), Besseling-van der Vaart I(4), Claassen E(5), de Weerth C(6).
Author information:
(1)Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Kapittelweg 29, 6525 EN, Nijmegen, The Netherlands. [Email]
(2)Faculty of Earth and Life Sciences, Athena Institute, VU University, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands. [Email]
(3)Department of Obstetrics and Gynecology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
(4)Winclove Probiotics BV, Amsterdam, The Netherlands.
(5)Faculty of Earth and Life Sciences, Athena Institute, VU University, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.
(6)Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Kapittelweg 29, 6525 EN, Nijmegen, The Netherlands. [Email]

Abstract

Probiotic use may be an efficacious treatment option to effectively manage symptoms of prenatal maternal anxiety and depression. Our primary aim was to test feasibility and acceptability for a probiotic randomized controlled trial (RCT) in pregnant women with pre-existing symptoms. This double-blind pilot RCT included 40 pregnant women with low-risk pregnancies and elevated depressive symptoms and/or anxiety. Once daily, participants orally consumed a probiotic (Ecologic Barrier) or a placebo, from 26 to 30 weeks gestation until delivery. A priori key progression criteria for primary outcomes were determined to decide whether or not a full RCT was feasible and acceptable. Secondary outcomes included depressive symptoms, anxiety, stress, and maternal bonding to offspring. In 19 months, 1573 women were screened; following screening, 155 women (10%) were invited for participation, of whom 135 (87%) received study information, and 40 women (30%) were included. Four out of six a priori determined criteria for success on feasibility and acceptability were met. After 8 weeks of intervention, there was no significant difference between the probiotic and placebo groups for secondary outcomes. The pilot trial was feasible and acceptable, but hampered by recruitment method and study design. Secondary endpoints did not reveal differences between the groups for improving maternal mood.