Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice
Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice: A Randomized Double-Blind Placebo-Controlled Parallel-Group Superiority Clinical Trial
Chinese University of Hong Kong
94 participants
Mar 23, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- All pregnant women aged 18-45 years old.
- Gestational age of 28-34 weeks
- Normal singleton pregnancy
Exclusion Criteria6
- 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.
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Interventions
The probiotic group participants will receive 1 sachet of probiotic product daily from 36weeks of gestation up to 7th day of postpartum while placebo groups will 1 sachet placebo prepared with the same colour, taste, and packaging with Vivomixx® daily for the same duration of probiotic groups. Vivomixx® is a non-genetically modified (GMO), gluten-free, high potency microbiotic food supplement, containing eight strains (Streptococcus thermophilus DSM24731® / NCIMB 30438, Bifidobacterium breve DSM24732® / NCIMB 30441, Bifidobacterium longum DSM24736® / NCIMB 30435, Bifidobacterium infantis DSM24737® / NCIMB 30436\*, Lactobacillus acidophilus DSM24735® / NCIMB 30442, Lactobacillus plantarum DSM24730® / NCIMB 30437, Lactobacillus paracasei DSM24733® / NCIMB 30439, Lactobacillus delbrueckii subsp. bulgaricus DSM24734® / NCIMB 30440) of live bacteria (450 billion bacteria per sachet).
A maltose- containing product with a similar phenotype with Vivomixx®.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06087874