Human Milk Oligosaccharides (HMOs) Profiles and Growth Indicators of Infants Aged 0-4 Months

NCT04515264 | Completed

• 1 other identifier: HMOs Indonesia 1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The breastfeeding rates globally in Indonesia generally remain low with only 40% or less infants aged 6 months are exclusively breastfed. Available national data in 2018 showed the proportion of wasted in children under 5 years old was 6.7%, while 3.5% children were severely wasted. This data showed improvement compared data in 2007 and 2013. While proportion children under 2 years old with stunted and severly stunted was 29.9%. As the third most abundant group of compounds in human milk, after lactose (70 g/L) and lipids (40 g/L), human milk oligosaccharides (HMOs) never been study in Indonesia. HMOs amount and diversity influenced by non modifiable and modifiable factors. The maternal phenotypes, the α-1-2-fucosyltransferase (FUT-2) gene and the α-1-3-4-fucosyltransferase (FUT-3) gene divided the mother into secretor (Se+) and non secretor (Se-) and Le+ or Le-). Studies showed the breastfed infants of non secretor mothers secrete lower HMOs than secretor mothers. By many functions in HMOs such as prebiotic, anti infection, modulate immunity, it is thought that HMOs can influence infant growth. The hypothesis of this study is to show the associations between maternal factors (secretor gene status/FUT-2 gene, lewis gene status/FUT-3 gene, gestational age and gestational weight gain) with HMOs profiles and growth indicators of infants aged 0-4 months.

Conditions

Growth; Stunting, Nutritional

Keywords

human milk oligosaccharides

Outcome Measures

Primary Outcomes (6)

• Weight for Age Z score (WAZ)

  weight-for-age z score WHO growth chart. Comparing the weight of infant with age based on WHO growth chart.

  Change from baseline WAZ at 2 months.

• Weight for Age Z score (WAZ)

  weight-for-age z score WHO growth chart. Comparing the weight of infant with age based on WHO growth chart.

  Change from baseline WAZ at 4 months.

• Weight for Length Z score (WLZ)

  weight-for-length z score WHO growth chart. Comparing the weight of infant with length based on WHO growth chart.

  Change from baseline WLZ at 2 months.

• Weight for Length Z score (WLZ)

  weight-for-length z score WHO growth chart. Comparing the weight of infant with length based on WHO growth chart.

  Change from baseline WLZ at 4 months.

• Weight velocity

  Comparing the infant weight gain with weight velocity chart from WHO

  Change from baseline weight velocity at 2 months.

• Weight velocity

  Comparing the infant weight gain with weight velocity chart from WHO

  Change from baseline weight velocity at 4 months.

Eligibility Criteria

• Age: 2 Weeks - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Target population of this study are post partum inpatient mothers in Government \& Private Hospital in Jakarta between July - Agustus 2020.

You may qualify if:

• Mother :
• Age of 18-45 year at the time of delivery
• Willing to breastfed at least up to 4 month
• Singleton birth

You may not qualify if:

• Mother :
• Type 1 or 2 diabetes before or during pregnancy
• Presenting conditions that contraindicate breastfeeding
• Smoking
• Infant :
• Congenital illness or malformation that could affect growth
• Infants received water or any other food besides breast milk

Sponsors & Collaborators

• Indonesia University: lead
• Wyeth nutrition indonesia: collaborator

Study Sites (1)

Universitas Indonesia

Jakarta, DKI Jakarta, Indonesia

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, breast milk

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Verawati Sudarma, Master

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: August 1, 2021
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)