NCT04050189

Validation of the In-utero Transmission of Probiotics

Validation of the In-utero Transmission of Probiotics From the Mother to the Baby: A Randomized Crossover Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

Summary

This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby. Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study. Women will take the investigational products between 34 weeks of pregnancy up to 10 days post-partum. Investigational products are probiotics (5 bacterial strains) compared to placebo.

Detailed description

Rational: Studies have shown that probiotics given to babies can reduce perinatal complications. A change of practice should therefore be introduced in the management of premature newborns. However, one could assume that probiotic administration before birth could be as effective if not more. Indeed, one could hypothesise that when the newborn is exposed to probiotics earlier, the protective effect is potentially increased. Objective: This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby. Population: Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study Products under study: Probiotics containing 5 bacterial strains (total of 12 million colony-forming unit / day) vs. Placebo. Procedure: At 32-33 weeks, participants will complete questionnaires (medical, obstetrical, socio-demographic data) and will be randomized (double-blind) in one of the 2 following groups: Group A: taking probiotics every day from the 34th week of pregnancy until delivery; taking placebo for 10 days after delivery. Group B: taking placebo every day from the 34th week of pregnancy until delivery; taking probiotics for 10 days after delivery. Follow-up: All women will complete a logbook to monitor the study products intake and monitor side effects until the end of the study (10 days postpartum). Samples: maternal stool samples, vaginal secretions, stool (and meconium) as well as breast milk (and colostrum) will be taken at different times of the study to confirm the presence of probiotics and transmission between the mother and the baby.

Conditions

• In Utero Drug Exposure

Interventions

Type	Name	Description
BIOLOGICAL	Natural products: Probiotics	Probiotics intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum
OTHER	Placebo	Placebo intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum

Timeline

• Start date: 2022-04-27
• Primary completion: 2023-08-28
• Completion: 2023-11-28
• First posted: 2019-08-08
• Last updated: 2023-12-05

Locations

1 site across 1 country: Canada