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

NCT05203900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-07-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Meiji Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2023-05-24
Completion
2023-05-24

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05203900 on ClinicalTrials.gov