Probiotics in Pregnancy pilot study

Not yet recruiting

• Conditions: anxiety, depression, pregnancy, probiotics

• Registration Number: NL-OMON26403
• Lead Sponsor: Behavioural Science Institute, Radboud University, Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

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)

Exclusion Criteria

1) Multiple pregnancy (increased obstetric risk);

2) High suicidal risk according to suicidality subscale score on the MINI International Neuropsychiatric Interview;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the number of successfully met<br>feasibility criteria linked to the intervention and study design.<br /><br>• feasibility of recruitment pathways (the ACCEPT checklist);<br /><br>• participant retention;<br /><br>• acceptability of study measures;<br /><br>• number of women in Wageningen region (the Netherlands) eligible for this pilot trial.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include:<br /><br>• Quantitative data assessing mental health in mothers (anxiety, stress and depression);<br /><br>• Crying behaviour in children;<br /><br>• Biological data, including maternal cortisol, maternal vaginal microbiota, maternal intestinal microbiota<br>and intestinal microbial composition, and infant intestinal<br>microbial composition