Probiotic supplementation during pregnancy to prevent neonatal jaundice
Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice: A Randomized Double-Blind Placebo-Controlled Parallel-Group Superiority Clinical Trial
This study is testing if giving pregnant women probiotics can help prevent jaundice in their newborns.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, New Territories) |
| Trial ID | NCT06087874 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of maternal perinatal probiotic supplementation on neonatal jaundice and related microbiomes. A total of 94 pregnant women will be randomly assigned to receive either the probiotic product Vivomixx® or a placebo starting from 36 weeks of gestation until one week postpartum. The study will collect biological samples from mothers and infants to analyze the impact of probiotics on bilirubin levels and microbiome composition. The trial aims to provide insights into how probiotics can influence neonatal health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18-45 years with a singleton pregnancy between 28-34 weeks of gestation.
Not a fit: Patients with fetal abnormalities or those on antibiotic medication during the study period may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of neonatal jaundice and its complications.
How similar studies have performed: While the use of probiotics in pregnancy is being explored, this specific approach to prevent neonatal jaundice is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hong Kong, New Territories
- Prince of Wales Hospital — Hong Kong, New Territories, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Chi C Wang, Professor — Chinese University of Hong Kong
- Study coordinator: Bekalu K Alemu
- Email: bekalukassie@link.cuhk.edu.hk
- Phone: (852) 63506068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.