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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infantile Colic, Breast Feeding, Atopic Dermatitis, Infant Formula

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New born 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

Ages Eligible for Study
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Minimum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast-milk feeding<br>Exclusive breastfeeding for 4 months or more | |
| Control Formula milk feeding<br>Exclusive formula milk for 4 months or more | |
| HMO-Formula-milk feeding<br>Exclusive HMO-formula milk for 4 months or more | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | Infant stool samples will be collected at various time points from 0 to 1 year of age. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | The 1 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. | 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. | 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. | 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. | The 12 months after birth follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast milk, microbiota, infant health, Human milk oligosaccharides, prebiotics