Abstract
BackgroundMaternal prenatal depressive or anxiety symptoms are associated with adverse maternal and infant health outcomes. With prevalence rates of maternal prenatal depression and anxiety ranging between 10 and 20%, attempts to identify effective interventions to reduce symptoms are priority. There are indications that probiotics can reduce symptoms of maternal depression or anxiety. Probiotics ingested by the mother may thus offer a promising and accessible intervention to complement existing treatments.MethodsThe Probiotics in Pregnancy (PIP) pilot trial is a double-blind, placebo-controlled, randomized pilot trial. While one group orally consumes a probiotic mixture (Ecologic® Barrier; 2,5 × 109 colony forming units/g; 2 g; daily), the other group consumes a placebo, from between 26 and 30 weeks gestation until delivery. Subjects are randomly allocated (1:1) to the intervention or placebo group. Forty healthy pregnant women with symptoms of depression or anxiety and uncomplicated pregnancies at randomization will be included. The primary aim is to determine the feasibility and acceptability of a probiotic trial to reduce symptoms of maternal depression or anxiety in pregnancy. The secondary aim is to exploratorily compare the potential effect of probiotics, compared to placebo, on depressive and/or anxiety symptoms, maternal stress (i.e. reported/hair cortisol), maternal vaginal and intestinal microbiota, and by possibly affecting maternal mood and microbiota, maternal bonding to offspring, infant microbiota and infant crying.DiscussionResults of this pilot trial will help determine whether or not to proceed with a full trial after the pilot trial, and if so, whether revisions should be made to the study protocol and procedures before conducting a full randomized controlled trial. Additionally, they are expected to provide insights into whether changes in psychological, behavioral and biological parameters can be attributed to the probiotic intervention.Trial registrationNetherlands Trial Register, NTR6219. Registered on 28 February 2017.
Highlights
Maternal prenatal depressive or anxiety symptoms are associated with adverse maternal and infant health outcomes
The primary objectives are to quantitatively and qualitatively assess (A) the proportion of pregnant women with depressive and/or anxiety symptoms accepting the invitation to participate in the pilot trial and the reasons why, (B) the proportion of women who complete the study, (C) adherence rates to the intervention schedule and (D) participants’ impressions and experiences during the pilot trial
For the per-protocol analysis, participants who are found ineligible after randomization or deviated from the probiotics/placebo product intake will be excluded from the main analysis
Summary
Maternal prenatal depressive or anxiety symptoms are associated with adverse maternal and infant health outcomes. With prevalence rates of maternal prenatal depression and anxiety ranging between 10 and 20%, attempts to identify effective interventions to reduce symptoms are priority. There are indications that probiotics can reduce symptoms of maternal depression or anxiety. Pregnancy can be accompanied by sadness and worry, as 10–20% of pregnant mothers report anxiety and depressive symptoms [1, 2]. Counseling and medical treatments are effective to reduce symptoms of maternal prenatal depression or anxiety. There is a need for safe, accessible and effective complementary interventions to treat maternal prenatal depression and anxiety. We will investigate the feasibility and acceptability of conducting a probiotic intervention from 26 to 30 weeks gestation until birth, for reducing maternal prenatal symptoms of depression or anxiety
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