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

Primary Purpose

Low Birth Weight Infants

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Infant formula with Human Milk Oligosaccharide
Infant formula without Human Milk Oligosaccharide
Sponsored by
Meiji Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Low Birth Weight Infants

Eligibility Criteria

undefined - 1 Month (Child)All SexesDoes not accept healthy volunteers

  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.

Sites / Locations

  • King Chulalongkorn Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Investigational formula

Control formula

Arm Description

Infant formula with Human Milk Oligosaccharide

Infant formula without Human Milk Oligosaccharide

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
December 23, 2021
Last Updated
June 29, 2023
Sponsor
Meiji Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05203900
Brief Title
The Influence by Dietary Human Milk Oligosaccharide in Low Birth Weight Infants
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
May 24, 2023 (Actual)
Study Completion Date
May 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meiji Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Birth Weight Infants

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational formula
Arm Type
Experimental
Arm Description
Infant formula with Human Milk Oligosaccharide
Arm Title
Control formula
Arm Type
Placebo Comparator
Arm Description
Infant formula without Human Milk Oligosaccharide
Intervention Type
Dietary Supplement
Intervention Name(s)
Infant formula with Human Milk Oligosaccharide
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Infant formula without Human Milk Oligosaccharide
Intervention Description
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 Outcome Measure Information:
Title
Growth factors concentration in infant's plasma
Description
The concentration of NGF-beta (pg/mL), BDNF (pg/mL), etc. in infant's plasma will be measured by immunoassay.
Time Frame
At one-month-old
Title
Cytokines concentration in infant's plasma
Description
The concentration of IFN-gamma (pg/mL), IL-1alpha (pg/mL), etc. in infant's plasma will be measured by immunoassay.
Time Frame
At one-month-old
Title
Infant's gut microbiota occupancy
Description
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).
Time Frame
At one-month-old

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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

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