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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast-milk feeding | Exclusive breastfeeding for 4 months or more | ||
| Control Formula milk feeding | Exclusive formula milk for 4 months or more | ||
| HMO-Formula-milk feeding | Exclusive HMO-formula milk for 4 months or more |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The investigators collected exclusive, formula-fed and HMO-supplement formula-fed infants. Inclusion criteria were infants with a gestational age >= 37 weeks and a birth weight greater than 2500 gm. Exclusion criteria were infants born with perinatal injury, use of antibiotics prior to stool collection, growth-related congenital anomalies, and major illnesses requiring hospitalization.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University & Hospital | Tainan | 704 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20679197 | Background | Zivkovic AM, German JB, Lebrilla CB, Mills DA. Human milk glycobiome and its impact on the infant gastrointestinal microbiota. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4653-8. doi: 10.1073/pnas.1000083107. Epub 2010 Aug 2. | |
| 29599768 | Background | Le Doare K, Holder B, Bassett A, Pannaraj PS. Mother's Milk: A Purposeful Contribution to the Development of the Infant Microbiota and Immunity. Front Immunol. 2018 Feb 28;9:361. doi: 10.3389/fimmu.2018.00361. eCollection 2018. |
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| ID | Term |
|---|---|
| D003085 | Colic |
| D001942 | Breast Feeding |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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infant fecal sample and mother breast-milk sample
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. |
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 |
| 16751577 | Background | Ward RE, Ninonuevo M, Mills DA, Lebrilla CB, German JB. In vitro fermentation of breast milk oligosaccharides by Bifidobacterium infantis and Lactobacillus gasseri. Appl Environ Microbiol. 2006 Jun;72(6):4497-9. doi: 10.1128/AEM.02515-05. |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |