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Clinical Trial Summary

Background: Human milk oligosaccharides (HMO) and microbiota are both key factors for infants to shape the gut flora and develop the immune system. Breastfed infant is beneficial to prevent the occurrence of infantile colic (IC) and atopic dermatitis (AD), which may through shaping a healthy microbiota. However, the gut microbiota biomarkers representing IC and AD have not yet been discovered. In addition, the effectiveness of supplement of HMO in infant formula reduce the incidence of IC and AD in infants is still debate.


Clinical Trial Description

Purpose: To investigate the preventive role of HMO-supplement formula on IC and AD in term infants in a clinical trial. Method: The investigators will enroll three cohorts (exclusive breastfeeding, formula feeding, and HMO-supplement formula feeding infants) for research. The investigators collected samples of serial baby feces from subjects at 0, 1, 2, 4, 6, 12 months in this study. The fecal microbiota composition will be analyzed by detecting 16S-rRNA using next generation sequencing method. The demographic data and incidence of IC (0-5 months) and AD (0-12 months) was followed and recorded. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05992493
Study type Observational
Source National Cheng-Kung University Hospital
Contact Yao-jong Yang, PhD
Phone +886 928 720 689
Email yaojong@mail.ncku.edu.tw
Status Recruiting
Phase
Start date August 7, 2023
Completion date August 30, 2026

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