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

To Explore and Develop the Effective Human Milk Oligosaccharides and Microbiomes on Maternal and Infant Health and Neurodevelopment in Early Infancy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05992493
Enrollment
300
Registered
2023-08-15
Start date
2023-08-07
Completion date
2026-08-30
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Breast Feeding, Infant Formula, Infantile Colic

Keywords

Breast milk, microbiota, infant health, Human milk oligosaccharides, prebiotics

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.

Interventions

None listed

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of IC and AD will be compared between three groupsThe 1 months after birth follow-upAccording 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 groupsInfant 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

MeasureTime frameDescription
Infantile weight growth between different feeding patternThe 1 months after birth follow-upSingleton 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 the three groups.
Infantile height growth between different feeding patternThe 1 months after birth follow-upSingleton 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026