Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05156255
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2021-12-01
Brief Title:
Profile of Human Milk Oligosaccharides and FUT2 Polymorphism of Mothers in Indonesia
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 -80C freezer The remaining is stored in a -20C 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 -80C storage before short chain fatty acid profile analysis
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 -80C freezer The remaining is stored in a -20C 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 -80C storage before short chain fatty acid profile analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None