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.
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 Type
OBSERVATIONAL
Enrollment
300
National Cheng Kung University & Hospital
Tainan, Taiwan
Incidence of IC and AD will be compared between three groups
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.
Time frame: The 1 months after birth follow-up
Incidence of IC and AD will be compared between three groups
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.
Time frame: The 2 months after birth follow-up
Incidence of IC and AD will be compared between three groups
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.
Time frame: The 4 months after birth follow-up
Incidence of IC and AD will be compared between three groups
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.
Time frame: The 6 months after birth follow-up
Incidence of IC and AD will be compared between three groups
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.
Time frame: The 12 months after birth follow-up
Next-generation sequencing analysis-based differences on gut microbiota in infants between three groups
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.
Time frame: Infant stool samples will be collected at various time points from 0 to 1 year of age.
Infantile weight growth between different feeding pattern
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 the three groups.
Time frame: The 1 months after birth follow-up
Infantile weight growth between different feeding pattern
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 the three groups.
Time frame: The 2 months after birth follow-up
Infantile weight growth between different feeding pattern
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 the three groups.
Time frame: The 4 months after birth follow-up
Infantile weight growth between different feeding pattern
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 the three groups.
Time frame: The 6 months after birth follow-up
Infantile weight growth between different feeding pattern
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.
Time frame: The 12 months after birth follow-up
Infantile height growth between different feeding pattern
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.
Time frame: The 1 months after birth follow-up
Infantile height growth between different feeding pattern
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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.
Time frame: The 2 months after birth follow-up
Infantile height growth between different feeding pattern
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.
Time frame: The 4 months after birth follow-up
Infantile height growth between different feeding pattern
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.
Time frame: The 6 months after birth follow-up
Infantile height growth between different feeding pattern
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.
Time frame: The 12 months after birth follow-up