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)

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.

Study Overview

• Status: Completed
• Conditions: Low Birth Weight Infants
• Intervention / Treatment: Dietary supplement: Infant formula with Human Milk Oligosaccharide; Dietary supplement: Infant formula without Human Milk Oligosaccharide

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No

Description

1. 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)

2. 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.

3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational formula; Infant formula with Human Milk Oligosaccharide	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.
Placebo Comparator: Control formula; Infant formula without Human Milk Oligosaccharide	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth factors concentration in infant's plasma	The concentration of NGF-beta (pg/mL), BDNF (pg/mL), etc. in infant's plasma will be measured by immunoassay.	At one-month-old
Cytokines concentration in infant's plasma	The concentration of IFN-gamma (pg/mL), IL-1alpha (pg/mL), etc. in infant's plasma will be measured by immunoassay.	At one-month-old
Infant's gut microbiota occupancy	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).	At one-month-old

Collaborators and Investigators

• Sponsor: Meiji Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): May 24, 2023
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 2020-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No