- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05156255
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
Study Overview
Status
Conditions
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:
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
DKI Jakarta
-
Jakarta Pusat, DKI Jakarta, Indonesia, 10440
- Faculty of Medicine, Universitas Indonesia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
1 day
|
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.
|
1 day
|
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.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day
|
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.
|
1 day
|
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.
|
1 day
|
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.
|
1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Klara Yuliarti, MD, Dept of Pediatric, Faculty of Medicine, Universitas Indonesia/ Cipto Mangunkusumo General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 21-08-0852
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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