Trials / Completed
CompletedNCT05156255
Profile of Human Milk Oligosaccharides and FUT2 Polymorphism of Mothers in Indonesia
Profile of Human Milk Oligosaccharides and FUT2 Polymorphism of Mothers in Indonesia: A Study on the Association Between Maternal Genotype-Phenotype Secretor Status and Short Chain Fatty Acid Profile Based on the Mother-Infant Genotype Pair
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (actual)
- Sponsor
- Indonesia University · Academic / Other
- Sex
- All
- Age
- 2 Weeks
- Healthy volunteers
- Accepted
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
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2022-07-31
- Completion
- 2023-04-14
- First posted
- 2021-12-14
- Last updated
- 2023-09-28
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT05156255. Inclusion in this directory is not an endorsement.