Actively Recruiting

Phase 2
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT06087874

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

Led by Chinese University of Hong Kong · Updated on 2024-05-20

94

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women aged 18 to 45 years old
  • Gestational age between 28 and 34 weeks
  • Normal singleton pregnancy
Not Eligible

You will not qualify if you...

  • Fetal abnormality
  • Mothers using antibiotic medication during the study allocation
  • Couples with glucose 6-phosphate dehydrogenase enzyme deficiency
  • Couples with known rhesus or hemolytic disease history
  • Plan to give birth at hospitals other than Prince of Wales Hospital
  • Known breast disorders or any contraindication for breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital

Hong Kong, New Territories, Hong Kong, 0852

Actively Recruiting

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Research Team

B

Bekalu K Alemu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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