NCT03310853

The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants

The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants: a Randomized, Double-blind, Placebo Controlled Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Lallemand Health Solutions · Industry
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

This phase 2 study evaluates the effect of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a health pregnancy. In addition, the effect of probiotics intake during pregnancy and breastfeeding on the infant's overall health status will be evaluated.

Detailed description

Throughout pregnancy women undergo many biological changes, including alterations in their microbiota. These infections can exacerbate pregnancy complications and increase the risk of preeclampsia and preterm birth. The present study aims to evaluate the potential effects of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a healthy pregnancy. Potential infections include but are not limited to influenza/colds, bacterial vaginosis, mastitis, candidiasis, urinary tract infection and gingivitis. Additionally, the benefits of probiotic intake by the mother on the infant during pregnancy and breastfeeding will be evaluated.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Dosing regimen of one capsule daily for a maximum of 18 weeks
OTHER	Placebo	Dosing regimen of one capsule daily for a maximum of 18 weeks

Timeline

• Start date: 2017-10-23
• Primary completion: 2022-05-20
• Completion: 2022-05-20
• First posted: 2017-10-16
• Last updated: 2023-02-02

Locations

1 site across 1 country: Canada