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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992493
• Other study ID #: A-BR-109-005
• Status: Recruiting
• Start date: August 7, 2023
• Est. completion date: August 30, 2026

Study information

• Verified date: August 2023
• Source: National Cheng-Kung University Hospital
• Contact: Yao-jong Yang, PhD
• Phone: +886 928 720 689
• Email: yaojong[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day and older

Eligibility

Inclusion Criteria:

1. New born

2. Gestational age of >= 37 weeks

3. birth weight greater than 2500 gm

Exclusion Criteria:

1. Born with Perinatal insults

2. Mother with antimicrobial agents 1 month before delivery

3. Congenital abnormalities related to growth

4. Major disease admitted to Level II or NICU

Related Conditions & MeSH terms

• Atopic Dermatitis
• Breast Feeding
• Colic
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Infant Formula
• Infantile Colic

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University & Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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