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

The Chinese University of Hong Kong

Status and phase: Enrolling; Phase 2

Conditions: Hyperbilirubinemia, Neonatal; Pregnancy Related; Microtia; Neonatal Jaundice

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vivomixx®

Study type: Interventional

Funder types: Other

Identifiers

NCT06087874

20230317

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

Vivomixx® is a multi-strain probiotics product.

Treatment:

Dietary Supplement: Vivomixx®

Placebo

Placebo Comparator group

Description:

Maltose-containing placebo product

Treatment:

Dietary Supplement: Placebo