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

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.

Figure 1

Participants’ flow through the study based on the Consolidated Standards of Reporting Trials (CONSORT) flow diagram. From the research database, participants were screened for eligibility and contacted by phone by the coordinating investigator whether they wanted to receive study information. Eligible participants who provided consent were randomized in either the probiotic or placebo group (t0). Measurements took place between baseline (t1) and 4 weeks post-partum (t2). Participants were recruited from March 2017 to September 2018.

Figure 2

Reasons for declining study participation as a percentage of the total number of women who were invited to join the pilot trial and provided reasons for declining participation (N = 60).

Figure 3

Depressive symptom scores of women in the probiotic (N = 20) and placebo groups (N = 20) measured at baseline (t0), 8 weeks after probiotic/placebo intake (t1) and 4 weeks postpartum (t2). *p < 0.05.

Figure 4

Anxiety symptom scores of women in the probiotic (N = 20) and placebo groups (N = 20) measured at baseline (t0), 8 weeks after probiotic/placebo intake (t1) and 4 weeks postpartum (t2).