An observational study in Infantile Colic, Breast Feeding and Atopic Dermatitis, sponsored by National Cheng-Kung University Hospital. Active, not recruiting at 1 site in Taiwan. Open to participants aged 1 Day and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by National Cheng-Kung University Hospital · Observational
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.
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's planned enrollment of 300 is close to the median of 300 across 11 observational studies indexed under Colic.
Browse Colic studies →National Cheng-Kung University Hospital is the lead sponsor of 277 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Exclusive breastfeeding for 4 months or more
Exclusive formula milk for 4 months or more
Exclusive HMO-formula milk for 4 months or more
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
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
Plan to share: Undecided
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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