Status:
ACTIVE_NOT_RECRUITING
Metagenomic & Metabolomic Study: Bifidobacterium Probiotic Effects on Gut Microbiota & SCFA in Preterm NICU Infants
Lead Sponsor:
Hasanuddin University
Conditions:
Prematurity
Low Birth Weight Neonates
Eligibility:
All Genders
Up to 3 years
Phase:
EARLY_PHASE1
Brief Summary
One million premature babies die due to prematurity complications, contributing the most to the causes of death in children under 5 years old. Indonesia ranks 5th among countries with the highest prem...
Eligibility Criteria
Inclusion
- Premature infants (gestational age 28 to \<34 weeks) treated in the NICU with a birth weight of 1000 to \<2500 grams
- No contraindications to giving the drink in the first 3 days of life
- Parents agree to participate in the study and sign a consent letter.
Exclusion
- Major congenital disorders
- Severe sepsis
- No stool production in the first 3 days of life
- Received formula milk that contains probiotics
Key Trial Info
Start Date :
September 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07213414
Start Date
September 2 2024
End Date
September 30 2025
Last Update
October 8 2025
Active Locations (3)
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1
Hasanuddin University General Hospital
Makassar, South Sulawesi, Indonesia, 90152
2
Dr. Wahidin Sudirohusodo General Hospital
Makassar, South Sulawesi, Indonesia, 90174
3
Cahaya Medika General Hospital
Makassar, South Sulawesi, Indonesia, 90245