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

NCT05203900 | Completed DMC

• 1 other identifier: 2020-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Investigational formula

EXPERIMENTAL

Infant formula with Human Milk Oligosaccharide

Dietary Supplement: Infant formula with Human Milk Oligosaccharide

Control formula

PLACEBO COMPARATOR

Infant formula without Human Milk Oligosaccharide

Dietary Supplement: Infant formula without Human Milk Oligosaccharide

Interventions

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.

Investigational formula

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.

Control formula

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ) 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.
• ) 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)

You may not qualify if:

• ) 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).
• ) 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.

Sponsors & Collaborators

• Meiji Co., Ltd.: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The number of anticipated participants is 60 mother-infant pairs. The 30 first enrolled mother-infant pairs are assigned to the investigational formula group, and the next 30 enrolled mother-infant pairs are assigned to the control formula group.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 24, 2022
• Study Start: December 13, 2021
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)