NCT03611647

Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The overarching goal of this project is to compare the microbiome profiles of healthy pregnant women, both before and after the introduction of a probiotic supplement into the maternal diet. Specifically, the investigators are performing a pilot randomized double-blinded placebo-controlled trial, comparing the microbiome profiles of 40 healthy pregnant women randomized to receive an oral probiotic containing a mixture of Lactobacillus and Bifidobacterium species (20 mothers) versus an oral placebo (20 mothers) during the first/second trimester of pregnancy. For each mother, the investigators will collect biospecimens from the vagina, rectum, and urine, both before intervention, and 4-6 weeks after intervention. These biospecimens will be analyzed to obtain their microbiome profiles using next-generation sequencing. The primary outcome of interest is the vaginal microbiome, with secondary outcomes including the microbiomes of the rectum and urine. Additionally, the investigators will collect clinical data from the mother's and infant's medical records to correlate our findings with pregnancy and postnatal outcomes.

Conditions

• Pregnancy Related

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Probiotic dietary supplement containing a mixture of Lactobacillus and Bifidobacterium species, taken by mouth once daily for 4-6 weeks.
DIETARY_SUPPLEMENT	Placebo	Placebo, taken by mouth once daily for 4-6 weeks.

Timeline

• Start date: 2018-04-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-08-02
• Last updated: 2019-04-11

Locations

3 sites across 1 country: United States