Preventive Effect of Prenatal Maternal Oral Probiotic Supplementation on Neonatal Jaundice (POPS Study): A Protocol for the Randomised Double-Blind Placebo-Controlled Clinical Trial
Abstract
Neonatal jaundice is a common and life-threatening health problem in newborns due to an excess of bilirubin. Gut flora may influence bilirubin metabolism, and the infant gut microbiome is often similar to the maternal gut. Maternal gut dysbiosis during pregnancy can be stabilized by probiotic supplementation. This study aims to evaluate the effect of prenatal maternal probiotic supplementation on the incidence of neonatal jaundice.
Methods and Analysis
This is a randomised double-blind placebo-controlled clinical trial involving 94 pregnant women in a Hong Kong hospital. Participants will receive either Vivomixx probiotic or a placebo from 36 weeks of gestation until 1 week postpartum. The primary outcome will be neonatal bilirubin levels, with secondary outcomes including microbiome profiles and pregnancy outcomes. Statistical analyses will assess the association of microbiome data with clinical outcomes.
Ethics and Dissemination
Ethics approval has been obtained, and findings will be published in peer-reviewed journals and presented at international conferences.
TRIAL REGISTRATION NUMBER: NCT06087874
PMID: 38851232 | DOI: 10.1136/bmjopen-2023-083641
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