Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice: A Randomized Double-Blind Placebo-Controlled Parallel-Group Superiority Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:
• All pregnant women aged 18-45 years old.
• Gestational age of 28-34 weeks
• Normal singleton pregnancy
Locations
Other Locations
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Bekalu K Alemu
bekalukassie@link.cuhk.edu.hk
(852) 63506068
Time Frame
Start Date: 2024-03-23
Estimated Completion Date: 2025-06
Participants
Target number of participants: 94
Treatments
Experimental: Probiotics
Vivomixx® is a multi-strain probiotics product.
Placebo_comparator: Placebo
Maltose-containing placebo product
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong