Clinical trial NCT06087874: Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice
Official title: Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice: A Randomized Double-Blind Placebo-Controlled Parallel-Group Superiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neonatal Jaundice
Microtia
Pregnancy Related
Hyperbilirubinemia, Neonatal
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Hyperbilirubinemia
timeFrame: 1 week since birth
measure: Transcutaneous bilirubin level
timeFrame: 1 week of life (after birth)
Secondary outcomes:
measure: Preterm birth
timeFrame: within two days of birth
measure: Number of participants with Initiation of labor
timeFrame: within two days of birth
measure: Mode of birth checklist
timeFrame: within two days of birth
measure: Birth weight
timeFrame: within two days of birth
measure: Apgar scores
timeFrame: within two days of birth
measure: Breast milk microbiome profile
timeFrame: From birth seventh day of postpartum
measure: Stool microbiome profile
timeFrame: From birth seventh day of postpartum
Other outcomes:
measure: Number of participants with Skin rash
timeFrame: From initiation of the intervention until 1 week postpartum
measure: Number of participants with Diarrhea
timeFrame: From initiation of the intervention until 1 week postpartum
measure: Number of participants with Abdominal bloating
timeFrame: From initiation of the intervention until 1 week postpartum
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi C Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References: