Last reviewed · How we verify
NCT06087874
Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice: A Randomized Double-Blind Placebo-Controlled Parallel-Group Superiority Clinical Trial
Phase 2 trial testing Vivomixx® in Neonatal Jaundice in 94 participants. Status unknown.
1 February 2025
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 94 |
| Start date | 23 March 2024 |
| Primary completion | 1 February 2025 |
| Estimated completion | 1 June 2025 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Vivomixx®
- Placebo
Conditions studied
- Neonatal Jaundice — all drugs for Neonatal Jaundice →
- Microtia — all drugs for Microtia →
- Pregnancy Related — all drugs for Pregnancy Related →
- Hyperbilirubinemia, Neonatal — all drugs for Hyperbilirubinemia, Neonatal →
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.
-
Hyperbilirubinemia
Time frame: 1 week since birth
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 n -
Transcutaneous bilirubin level
Time frame: 1 week of life (after birth)
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.
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):
-
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:
- PubMed search for NCT06087874
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Vivomixx®
Trials testing the same drug.
- NCT03906578 — Effects of a Probiotic in Hypertension · NA · active not recruiting
- NCT02957591 — Probiotic Supplementation in Severe Depression · NA · completed
Other recruiting trials for Neonatal Jaundice
Currently open trials in the same condition.
- NCT06963450 — NeoSCB App for Screening Jaundice in Newborns · recruiting
- NCT06399146 — Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Population in Botswana · NA · recruiting
- NCT05521607 — Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago) · NA · recruiting
Other Chinese University of Hong Kong trials
Trials by the same sponsor.
- NCT07508644 — RSV Vaccination to Reduce Recurrent AECOPD · Phase 4 · not yet recruiting
- NCT07230457 — Plasma MTB cfDNA Before Bronchoscopy · not yet recruiting
- NCT07288671 — Nostalgia Intervention on Alleviating Loneliness Amongst Older Adults · NA · not yet recruiting
- NCT07256457 — Postoperative Pulmonary Function Assessment Based on Deep Learning Study · NA · not yet recruiting
- NCT06904209 — Can Artificial Intelligence Reduce Consumption of Standard High Volume Bowel Preparation Regimen Among Older Population, · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06087874 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 17 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06087874.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing