Skip to main content
OpenTrials
Completed

NCT Number: NCT05203900

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Birth Weight Infants

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:

1-1) For infants

i. Low birth weight infants (defined as a birth weight ≥1,500 g and <2,500 g) during hospitalization and may require milk powder formula as supplement.

1-2) For mothers

i. Mothers who do not find serious viral infection

ii. Mothers who are willing to provide consent for provision of study required information and specimen(s) from both mothers and infants

iii. Mothers who are willing to provide consent as infant's legally acceptable representative (LAR)

  • Exclusion Criteria:

2-1) For infants

i. Infants who receive any formulas before Informed Consent.

ii. Infants with serious infections.

iii. Infants with necrotizing enteritis.

iv. Infants with gastrointestinal perforation.

v. Infants whom the PI determines inappropriate as a study subject (e.g. inflammatory, metabolic abnormalities and difficulty in enteral feeding).

2-2) For mothers

i. Mothers the PI determines inappropriate as a study subject

ii. Mothers under 18 years old.

  • Withdrawal criteria:

A subject must be discontinued from treatment with test formula if any of the following apply:

i. If the mother, who is a subject of the study as well as infant's LAR , asks for withdrawal from the study or withdraws consent.

ii. When a serious adverse event occurs.

iii. When an adverse event occurs, and the PI or co-investigator determines that the study should be discontinued.

iv. If it is decided that there is a risk of compromising the safety of the study subject.

v. If a subject is found to be ineligible after the start of the study.

vi. If it is found that there is a serious or continued non-compliance with the study protocol by a study subject.

vii. In addition, if the PI decides to end the study.

Treatment and study plan

Infant formula with Human Milk Oligosaccharide

Dietary Supplement

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.

Infant formula without Human Milk Oligosaccharide

Dietary Supplement

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.

Primary outcomes

  1. Growth factors concentration in infant's plasma

    Time frame: At one-month-old

    The concentration of NGF-beta (pg/mL), BDNF (pg/mL), etc. in infant's plasma will be measured by immunoassay.

  2. Cytokines concentration in infant's plasma

    Time frame: At one-month-old

    The concentration of IFN-gamma (pg/mL), IL-1alpha (pg/mL), etc. in infant's plasma will be measured by immunoassay.

  3. Infant's gut microbiota occupancy

    Time frame: At one-month-old

    Total bacterial counts and bifidobacterial counts in stool will be measured by RT-PCR (copy/g wet feces). Occupancy of microbiota in infant's stool will be comprehensively analyzed by DNA/RNA Sequencing (percent).

Sponsors and collaborators

Lead sponsor

Meiji Co., Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 24, 2022
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.