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Completed

NCT Number: NCT05156255

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

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.

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Key information

Conditions

Breastfeeding, Exclusive Behavior Breast Feeding Feeding Behavior

Age range

2 week and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10440, Indonesia

About this study

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:

  • Mother
  • 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.

  • Blood

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

  • Infant
  • Buccal cells

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

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mother
  • Minimum of 18 years old
  • With term infants aged 2-5 weeks
  • Exclusively breastfeed
  • Healthy condition
  • Agree to participate and sign the informed consent
  • Infant
  • Infant with mother who fulfil the eligibility criteria

Exclusion criteria

  • Mother
  • Has a Caucasian ancestor in two generations above
  • Infant has multiple congenital anomalies
  • Infant
  • Has ever received antibiotics

Treatment and study plan

Primary outcomes

  1. Human milk oligosaccharides profile of Indonesian mothers

    Time frame: 1 day

    The concentration of 19 HMOs will be measured using high performance anion exhange chromatography with pulsed amperometric detection (HPAEC-PAD).

  2. Proportion of FUT2 secretor genotype of mothers based on single nucleotide polymorphism (SNP) rs601338

    Time frame: 1 day

    Sequencing of coding sequence (exon 2) of FUT2 gene will be performed using a previously known outer primer from the study by Lefebvre, et al (2020). The results will be aligned with database from www.ncbi.nlm.nih.gov to find the proportion of rs601338 among mothers.

  3. Association between rs601338 FUT2 secretor genotype and 2'-FL secretor phenotype in mothers

    Time frame: 1 day

    The association between rs601338 FUT2 genotype (homozygous dominant, heterozygous, homozygous recessive) and 2'-FL concentration will be analysed using ANOVA test.

Secondary outcomes

  1. Novel FUT2 polymorphism in Indonesian mothers

    Time frame: 1 day

    The sequencing result of exon 2 in the FUT2 gene will be aligned with database from www.ncbi.nlm.nih.gov to find novel variants. Additional information regarding existing variants will be browsed using the same database. The allele frequency of new variants will be calculated to determine new SNP.

  2. Proportion of FUT2 secretor genotype of infants based on single nucleotide polymorphism (SNP) rs601338

    Time frame: 1 day

    Sequencing of coding sequence (exon 2) of FUT2 gene will be performed using a previously known outer primer from the study by Lefebvre, et al (2020). The results will be aligned with database from www.ncbi.nlm.nih.gov to find the proportion of rs601338 among infants.

  3. Novel FUT2 polymorphism in infant

    Time frame: 1 day

    The sequencing result of exon 2 FUT2 will be aligned with database from www.ncbi.nlm.nih.gov to find novel variants. Additional information regarding existing variants will be browsed using the same database. The allele frequency of new variants will be calculated to determine new SNP.

  4. Profile of infant stool short chain fatty acid based on mother-infant FUT2 genotype pairs

    Time frame: 1 day

    The concentration of total short chain fatty acid, acetate, propionate, and butyrate in infant's stool will be measured using gas chromatography-mass spectrometry (GC-MS). Difference in the concentration between four mother-infant genotype pairs will be analysed using ANOVA test.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • University Medical Center Groningen

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 14, 2021
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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