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临床试验/NCT05156255
NCT05156255已完成不适用

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

Indonesia University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Association between rs601338 FUT2 secretor genotype and 2'-FL secretor phenotype in mothers

研究概览

简要总结

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.

详细描述

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. 2. Blood

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
2 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 with mother who fulfil the eligibility criteria

排除标准

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

结局指标

主要结局

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

时间窗: 1 day

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

Human milk oligosaccharides profile of Indonesian mothers

时间窗: 1 day

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

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

时间窗: 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.

次要结局

  • Profile of infant stool short chain fatty acid based on mother-infant FUT2 genotype pairs(1 day)
  • Novel FUT2 polymorphism in infant(1 day)
  • Novel FUT2 polymorphism in Indonesian mothers(1 day)
  • Proportion of FUT2 secretor genotype of infants based on single nucleotide polymorphism (SNP) rs601338(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Klara Yuliarti

MD

Indonesia University

研究点 (1)

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