NCT05203900

The Influence by Dietary Human Milk Oligosaccharide in Low Birth Weight Infants

An Investigation of the Influence by Dietary Human Milk Oligosaccharide on Growth Factors and Cytokines in Blood, and Gut Microbiota in Low Birth Weight Infants (a Non-blinded Pilot Clinical Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Meiji Co., Ltd. · Industry
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the concentration of various growth factors and cytokines in blood, and to examine the gut microbiota of low birth weight infants fed with formulas with or without Human Milk Oligosaccharide (HMO) supplement. Eligible low birth weight infants are allocated to two groups, Investigational formula (with HMO) or Control formula (without HMO). The subjects are taking the assigned formula when they need to be supplemented with formula. After the informed consent was obtained and eligibility was confirmed, the intervention period begins, and ends at the one-month-old medical check-up with the assessment of the various blood growth factors and cytokines, and the gut microbiota.

Conditions

• Low Birth Weight Infants

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Infant formula with Human Milk Oligosaccharide	Although breastfeeding is encouraged, the shortage is supplemented with the investigational formula. After obtaining the informed consent, the investigational formula is administered to infants under the doctor's direction until a medical check-up at one-month-old.
DIETARY_SUPPLEMENT	Infant formula without Human Milk Oligosaccharide	Although breastfeeding is encouraged, the shortage is supplemented with the control formula. After obtaining the informed consent, the control formula is administered to infants under the doctor's direction until a medical check-up at one-month-old.

Timeline

• Start date: 2021-12-13
• Primary completion: 2023-05-24
• Completion: 2023-05-24
• First posted: 2022-01-24
• Last updated: 2023-07-03

Locations

1 site across 1 country: Thailand