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

Sponsor
Indonesia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05156255
Collaborator
University Medical Center Groningen (Other)
100
Enrollment
1
Location
10
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    2. 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.

    1. Blood

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

    1. Infant

    2. Buccal cells

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

    1. 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official 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
    Actual Study Start Date :
    Dec 1, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Human milk oligosaccharides profile of Indonesian mothers [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 [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 [1 day]

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

    Secondary Outcome Measures

    1. Novel FUT2 polymorphism in Indonesian mothers [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Weeks and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bunda Jakarta Woman and Children Hospital Jakarta Pusat DKI Jakarta Indonesia 10350

    Sponsors and Collaborators

    • Indonesia University
    • University Medical Center Groningen

    Investigators

    • Principal Investigator: Klara Yuliarti, MD, Dept of Pediatric, Faculty of Medicine, Universitas Indonesia/ Cipto Mangunkusumo General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Klara Yuliarti, MD, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT05156255
    Other Study ID Numbers:
    • 21-08-0852
    First Posted:
    Dec 14, 2021
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Klara Yuliarti, MD, Indonesia University
    Human Milk Oligosaccharide
    Short Chain Fatty Acid

    Study Results

    No Results Posted as of Jan 6, 2022