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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
48
Probiotic dietary supplement containing a mixture of Lactobacillus and Bifidobacterium species, taken by mouth once daily for 4-6 weeks.
Placebo, taken by mouth once daily for 4-6 weeks.
UCSD, La Jolla Clinic, 8910 Villa La Jolla Drive
La Jolla, California, United States
UCSD, Hillcrest Clinic, Medical Offices South
San Diego, California, United States
UCSD, Sorrento Valley Clinic, Directors Place
San Diego, California, United States
Change in Vaginal Microbiome, 16S rRNA
Time frame: Baseline, and 4-6 weeks after intervention
Change in Rectal Microbiome, 16S rRNA
Time frame: Baseline, and 4-6 weeks after intervention
Change in Urinary Microbiome, 16S rRNA
Time frame: Baseline, and 4-6 weeks after intervention
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