The Role of Human Milk Oligosaccharides and Microbiomes on Infantile Colic and Atopic Dermatitis in Term Infants

National Cheng-Kung University

Status: Active, not recruiting

Conditions: Atopic Dermatitis; Infantile Colic; Breast Feeding; Infant Formula

Study type: Observational

Funder types: Other

Identifiers

NCT05992493

A-BR-109-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 1+ day old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. New born
2. Gestational age of >= 37 weeks
3. birth weight greater than 2500 gm

Exclusion criteria

1. Born with Perinatal insults
2. Mother with antimicrobial agents 1 month before delivery
3. Congenital abnormalities related to growth
4. Major disease admitted to Level II or NICU

Trial design

300 participants in 3 patient groups

Breast-milk feeding

Description:

Exclusive breastfeeding for 4 months or more

Control Formula milk feeding

Description:

Exclusive formula milk for 4 months or more

HMO-Formula-milk feeding

Description:

Exclusive HMO-formula milk for 4 months or more