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Breastfeeding, ExclusiveNCT05156255

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

An observational study of Breastfeeding, Exclusive, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 weeks and olderHealthy volunteers can take part
Conditions the study is for
Breastfeeding, Exclusive
How many people
120 participants
Where
1 siteIndonesia
Study dates
1 Dec 2021to 14 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 weeks and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Eligible mothers and infants visiting the research site during recruitment.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Faculty of Medicine, Universitas Indonesia

    Jakarta Pusat, DKI Jakarta, 10440

Other trials in Indonesia

About this study

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

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.

Read the 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.
  3. Blood Blood samples (3 mL) are collected for DNA extraction.
  4. Infant
  5. Buccal cells Buccal swab kits are used to obtain samples for DNA extraction.
  6. 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.

Keywords
Human Milk Oligosaccharide, Short Chain Fatty Acid
Medical subject headings
Breast Feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Human milk oligosaccharides profile of Indonesian mothers

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

    Measured: 1 day

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

    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.

    Measured: 1 day

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

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

    Measured: 1 day

Secondary outcomes (4)

  1. Novel FUT2 polymorphism in Indonesian mothers

    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.

    Measured: 1 day

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

    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.

    Measured: 1 day

  3. Novel FUT2 polymorphism in infant

    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.

    Measured: 1 day

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

    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.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start1 Dec 2021
  3. Primary completion31 Jul 2022
  4. Study completion14 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05156255
Sponsor's protocol ID
21-08-0852
Status last verified
Sep 2023
First submitted
1 Dec 2021
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breastfeeding, Exclusive, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Human milk oligosaccharides profile of Indonesian mothers (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05156255.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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