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

NCT06087874 | Recruiting Phase 2

• 1 other identifier: 20230317
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Jaundice; Microtia; Pregnancy Related; Hyperbilirubinemia, Neonatal

Outcome Measures

Primary Outcomes (2)

• Hyperbilirubinemia

  Investigators will measure the transcutaneous bilirubin level on the second and seventh day of life and plot the record on the nomograph. The record above the 95th percentile will be taken as considerable hyperbilirubinemia and then the baby will be investigated for total serum bilirubin measurement if needed to declare hyperbilirubinemia. The outcome will be classified as hyperbilirubinemia and non-hyperbilirubinemia.

  1 week since birth

• Transcutaneous bilirubin level

  Infant's skin bilirubin level on the chest measured using a non-invasive devise called Drager meter. It will be measured in milligram per decilitre or micromole per liter. This outcome will be measured as a continuous outcome.

  1 week of life (after birth)

Secondary Outcomes (7)

• Preterm birth

  within two days of birth

• Number of participants with Initiation of labor

  within two days of birth

• Mode of birth checklist

  within two days of birth

• Birth weight

  within two days of birth

• Apgar scores

  within two days of birth

Other Outcomes (3)

• Number of participants with Skin rash

  From initiation of the intervention until 1 week postpartum

• Number of participants with Diarrhea

  From initiation of the intervention until 1 week postpartum

• Number of participants with Abdominal bloating

  From initiation of the intervention until 1 week postpartum

Study Arms (2)

Probiotics

EXPERIMENTAL

Vivomixx® is a multi-strain probiotics product.

Dietary Supplement: Vivomixx®

Placebo

PLACEBO COMPARATOR

Maltose-containing placebo product

Dietary Supplement: Placebo

Interventions

Vivomixx® DIETARY_SUPPLEMENT

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).

Probiotics

Placebo DIETARY_SUPPLEMENT

A maltose- containing product with a similar phenotype with Vivomixx®.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All pregnant women aged 18-45 years old.
• Gestational age of 28-34 weeks
• Normal singleton pregnancy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, New Territories, 0852, Hong Kong

RECRUITING

Related Publications (1)

• Alemu BK, Lee MW, Leung MBW, Lee WF, Wang Y, Wang CC, Lau SL. Preventive effect of prenatal maternal oral probiotic supplementation on neonatal jaundice (POPS Study): A protocol for the randomised double-blind placebo-controlled clinical trial. BMJ Open. 2024 Jun 8;14(6):e083641. doi: 10.1136/bmjopen-2023-083641.

  PMID: 38851232 DERIVED

MeSH Terms

Conditions

Jaundice, Neonatal; Congenital Microtia; Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities

Study Officials

• Chi C Wang, Professor

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bekalu K Alemu

CONTACT

(852) 63506068; bekalukassie@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It is a double-blind study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 18, 2023
• Study Start: March 23, 2024
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after initiation of the study
• Access Criteria: official request and memorandum of understanding signing

Locations

HK (1)