NCT06087874

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Neonatal jaundice is a yellowish discoloration of the skin and sclera because of over-concentration of circulating unconjugated bilirubin (hyperbilirubinemia) in the body. It can lead the baby to severe complications including death. Intestinal flora modulation by probiotics administration to the mother may tackle this problem. Therefore, investigators designed a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group). Eligible pregnant women will be recruited voluntarily at 28-36 weeks of gestation and allocated randomly to either the probiotic group (Vivomixx®) or placebo group (maltose-containing unit) which are phenotypically similar. Participants will take one sachet of the product per day starting from 36 weeks of gestation until the end of first week of postpartum. Biological samples (maternal stool, breast milk, and neonatal faeces) will be collected at different time points. Additionally, neonatal transcutaneous bilirubin will be measured on the second and seventh day of life using a Drager Meter (a transcutaneous bilirubinometer). The microbial DNA will be extracted from biological samples using commercial kits and metagenomics sequencing will be employed and will be correlated with bilirubin level using appropriate statistical methods. This study will be conducted based on the Helsinki Declaration and International Council for Harmonization Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) standards. Ethical approval is obtained from the Joint Chinese University of Hong Kong and New Territories East Cluster (CUHK-NTEC) Clinical Research Ethics Committee, Hong Kong with reference number: 2023.100-T. Written informed consent will be obtained from each participant during enrolment.

Conditions

• Neonatal Jaundice
• Microtia
• Pregnancy Related
• Hyperbilirubinemia, Neonatal

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vivomixx®	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).
DIETARY_SUPPLEMENT	Placebo	A maltose- containing product with a similar phenotype with Vivomixx®.

Timeline

• Start date: 2024-03-23
• Primary completion: 2025-02-01
• Completion: 2025-06-01
• First posted: 2023-10-18
• Last updated: 2024-05-20

Locations

1 site across 1 country: Hong Kong