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

Active, not recruiting

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

• Registration Number: NCT05992493
• Lead Sponsor: National Cheng-Kung University Hospital

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2022-09-30
• Study Start: 2023-08-07
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of IC and AD will be compared between three groups	The 12 months after birth follow-up	According to the feeding method, singleton full-term infants will divide into three groups (n=300) including recorded demographic data. The diagnosis of IC and AD is based on Rome IV criteria and the Taiwan Academy of Pediatric Allergy, Asthma, and Immunology (TAPAAI) criteria, respectively. The incidence of IC and AD will be compared between the three groups.
Next-generation sequencing analysis-based differences on gut microbiota in infants between three groups	Infant stool samples will be collected at various time points from 0 to 1 year of age.	Singleton full-term infants will divide into three groups (n=300) according to feeding method. The collected fecal samples will be analyze the composition of microbiota using NGS method. The differences of microbiota pattern will be identified.

Secondary Outcome Measures

Name	Time	Method
Infantile height growth between different feeding pattern	The 12 months after birth follow-up	Singleton full-term infants will divide into three groups (n=300) according to feeding method. The body height growth (cm) will be recorded and compared between the three groups.
Infantile weight growth between different feeding pattern	The 12 months after birth follow-up	Singleton full-term infants will divide into three groups (n=300) according to feeding method. The body weight growth (gm) will be recorded and compared between three groups.

Trial Locations

Locations (1)

National Cheng Kung University & Hospital; 🇨🇳 Tainan, Taiwan