RecruitingPhase 2

Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice

Hong Kong94 participantsStarted 2024-03-23

Plain-language summary

This is a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group) to investigate the effect of maternal perinatal probiotic supplementation on neonatal jaundice, breast milk microbiome, maternal stool, and infant fecal microbiome. Vivomixx®-probiotic product will be used as treatment and placebo as a control.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All pregnant women aged 18-45 years old. * Gestational age of 28-34 weeks * Normal singleton pregnancy Exclusion Criteria: * Foetal abnormality * Mothers with antibiotic medication during the allocation * Couples with glucose 6-phosphate dehydrogenase enzyme deficiency * Couples with known rhesus or haemolytic disease history * Plan of place of birth at other hospitals other than Prince of Wales Hospital * known breast disorder or any contraindication for breastfeeding.

What they're measuring

Hyperbilirubinemia

Timeframe: 1 week since birth

Transcutaneous bilirubin level

Timeframe: 1 week of life (after birth)

Trial details

NCT IDNCT06087874

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02

Contact for this trial

Bekalu K Alemu

(852) 63506068 bekalukassie@link.cuhk.edu.hk

View on ClinicalTrials.gov More Neonatal Jaundice trials