Profile of Human Milk Oligosaccharides and FUT2 Polymorphism of Mothers in Indonesia

NCT ID: NCT05156255

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-04-14

Brief Summary

Human milk oligosaccharides (HMOs), the third most abundant constituent of breastmilk, are known to have beneficial effects on infant immunity. Maternal genetic polymorphisms cause HMO variability. The FUT2 gene determines the secretor status, whereas the FUT3 gene is responsible for the expression of Lewis fucosyltransferase. Therefore, breastmilk can be classified to four groups according to the variation. To date, this variability has not been investigated in Indonesia. This study aims to evaluate the association between FUT2 gene polymorphism and 2'-Fucosyllactose (2'-FL) secretor phenotype. In addition, infant FUT2 gene polymorphism and short chain fatty acid (SCFA) profile from stool samples are also analysed.

Detailed Description

Eligible mother-infant pairs are explained about this study. Those willing to participate in this study are asked for written informed consent. Mothers are interviewed about their baseline characteristics, family pedigree, nutritional intake, and routine drug consumption. Infants are checked for their birth history. Both are measured for weight and height.

Four specimens are collected from the subjects:

1. Mother

1. Breastmilk

Breastmilk is expressed at 8-11 AM to avoid variability due to circadian rhythm. One breast is emptied, 30 mL of breastmilk is stored in a sterile container, and the rest is returned for feeding. Breastmilk is divided to five 2-mL cryovials and stored in a -80°C freezer. The remaining is stored in a -20°C freezer.

2. Blood

Blood samples (3 mL) are collected for DNA extraction.

2. Infant

1. Buccal cells

Buccal swab kits are used to obtain samples for DNA extraction.

2. Stool

Stool specimens are collected at the age of four weeks in a sterile container and stored in a -80°C storage before short chain fatty acid profile analysis.

Conditions

Breastfeeding, Exclusive

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Mother

1. Minimum of 18 years old

2. With term infants aged 2-5 weeks

3. Exclusively breastfeed

4. Healthy condition

5. Agree to participate and sign the informed consent

• Infant

1. Infant with mother who fulfil the eligibility criteria

Exclusion Criteria

• Mother

1. Has a Caucasian ancestor in two generations above

2. Infant has multiple congenital anomalies

• Infant

1. Has ever received antibiotics

• Minimum Eligible Age: 2 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Klara Yuliarti

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Klara Yuliarti, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Pediatric, Faculty of Medicine, Universitas Indonesia/ Cipto Mangunkusumo General Hospital

Locations

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

21-08-0852

Identifier Type: -

Identifier Source: org_study_id