To Explore and Develop the Effective Human Milk Oligosaccharides and Microbiomes on Maternal and Infant Health and Neurodevelopment in Early Infancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Incidence of IC and AD will be compared between three groups
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Day to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Gestational age of >= 37 weeks
- •birth weight greater than 2500 gm
Exclusion Criteria
- •Born with Perinatal insults
- •Mother with antimicrobial agents 1 month before delivery
- •Congenital abnormalities related to growth
- •Major disease admitted to Level II or NICU
Outcomes
Primary Outcomes
Incidence of IC and AD will be compared between three groups
Time Frame: 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
Time Frame: 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 Outcomes
- Infantile height growth between different feeding pattern(The 12 months after birth follow-up)
- Infantile weight growth between different feeding pattern(The 12 months after birth follow-up)
Investigators
Yao-Jong Yang
professor
National Cheng-Kung University Hospital