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NCT06087874

Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice: A Randomized Double-Blind Placebo-Controlled Parallel-Group Superiority Clinical Trial

Status unknown Phase 2 Last updated 17 May 2024
What this trial tests

Phase 2 trial testing Vivomixx® in Neonatal Jaundice in 94 participants. Status unknown.

Timeline
23 March 2024
Primary endpoint
1 February 2025
1 June 2025

Quick facts

Lead sponsorChinese University of Hong Kong
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment94
Start date23 March 2024
Primary completion1 February 2025
Estimated completion1 June 2025
Sites1 location across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

Chinese University of Hong Kong

Who can join

Adults 18 to 45, female only, with Neonatal Jaundice or Microtia. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Preventive effect of prenatal maternal oral probiotic supplementation on neonatal jaundice (POPS Study): A protocol for the randomised double-blind placebo-controlled clinical trial.
    Alemu BK, Lee MW, Leung MBW, Lee WF, et al · · 2024 · cited 5× · PMID 38851232 · DOI 10.1136/bmjopen-2023-083641

Verify or expand the search:

Other trials of Vivomixx®

Trials testing the same drug.

Other recruiting trials for Neonatal Jaundice

Currently open trials in the same condition.

Other Chinese University of Hong Kong trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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