Probiotics in Pregnancy pilot study

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2017
INTERVENTION: Subjects will be randomly allocated to either control group (placebo) or intervention probiotic group. Probiotic/placebo intake once daily for 8 up to 14 constituent weeks. CONDITION: Anxiety, Depression, Pregnancy, Probiotics ; ; PRIMARY OUTCOME: The primary outcome is the number of successfully met; feasibility criteria linked to the intervention and study design.; ; • feasibility of recruitment pathways (the ACCEPT checklist);; ; • participant retention;; ; • acceptability of study measures;; ; • number of women in Wageningen region (the Netherlands) eligible for this pilot trial. SECONDARY OUTCOME: Secondary outcomes include: ; ; • Quantitative data assessing mental health in mothers (anxiety, stress and depression); ; ; • Crying behaviour in children; ; ; • Biological data, including maternal cortisol, maternal vaginal microbiota, maternal intestinal microbiota ; and intestinal microbial composition, and infant intestinal ; microbial composition INCLUSION CRITERIA: 1. Healthy pregnant women (>18 years) in obstetric care in the Netherlands with at least elevated symptoms of depression and/or anxiety (resp. EDS = 10; STAI‐S > 40) 2. Women who can start daily probiotic intake from =26 weeks gestational age until delivery (Gestation is based on last menstrual period and early ultrasound)
Epistemonikos ID: c1da91cc4c536b044e0355a0af68ed8ea6909c59
First added on: Aug 23, 2024