Synbiotics in Patients at Risk for Preterm Birth: a Multi-center Double-blind Randomized Placebo-controlled Trial

What this Trial Is About

Prematurity is a leading cause of newborn death and serious health issues, including developmental delays, frequent hospital visits, and sensory problems. It also places significant emotional and financial strain on families and society. Women who have had a previous preterm delivery before 37 weeks are considered at high risk for delivering early again. Infections caused by an unstable vaginal microbiome may contribute to preterm birth, while a healthy vaginal flora is more resistant to infections in pregnancies that reach full term. This trial evaluates whether taking synbiotics, a combination of probiotics and prebiotics, from early pregnancy can improve vaginal flora and reduce the risk of preterm birth in women with a history of preterm delivery. Participants will be randomly assigned to receive either an oral synbiotic supplement containing eight probiotic Lactobacillus strains with prebiotics or a matching placebo. The study begins in the first trimester and continues through pregnancy. Participants will be monitored for changes in their vaginal microbiome at three points during pregnancy and followed until delivery. Researchers will assess pregnancy duration and the occurrence of preterm birth, as well as neonatal outcomes such as admissions to intensive care and birth weight. Maternal health, quality of life during pregnancy, and hospital admissions will also be evaluated. The study lasts until delivery, with some evaluations extending up to one year after birth.

Synbiotics in Patients at RIsk fOr Preterm Birth