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

NCT05992493 | Active Not Recruiting

• 1 other identifier: A-BR-109-005
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infantile Colic; Breast Feeding; Atopic Dermatitis; Infant Formula

Keywords

Breast milk; microbiota; infant health; Human milk oligosaccharides; prebiotics

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• Infantile weight growth between different feeding pattern

  The 1 months after birth follow-up

• Infantile weight growth between different feeding pattern

  The 2 months after birth follow-up

• Infantile weight growth between different feeding pattern

  The 4 months after birth follow-up

• Infantile weight growth between different feeding pattern

  The 6 months after birth follow-up

• Infantile weight growth between different feeding pattern

  The 12 months after birth follow-up

Study Arms (3)

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

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• New born
• Gestational age of \>= 37 weeks
• birth weight greater than 2500 gm

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University & Hospital

Tainan, 704, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 20679197 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.

  PMID: 29599768 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.

  PMID: 16751577 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

infant fecal sample and mother breast-milk sample

MeSH Terms

Conditions

Colic; Breast Feeding; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Feeding Behavior; Behavior; Skin Diseases, Genetic; Genetic Diseases, Inborn; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: August 15, 2023
• Study Start: August 7, 2023
• Primary Completion: August 30, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

TW (1)