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NCT Number: NCT05992493

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infantile Colic Atopic Dermatitis Behavior Breast Feeding Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Feeding Behavior Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infant Formula Infant, Newborn, Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

1 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cheng Kung University & Hospital

Tainan, 704, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of IC and AD will be compared between three groups

    Time frame: The 1 months after birth follow-up

    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.

  2. Incidence of IC and AD will be compared between three groups

    Time frame: The 2 months after birth follow-up

    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.

  3. Incidence of IC and AD will be compared between three groups

    Time frame: The 4 months after birth follow-up

    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.

  4. Incidence of IC and AD will be compared between three groups

    Time frame: The 6 months after birth follow-up

    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.

  5. Incidence of IC and AD will be compared between three groups

    Time frame: The 12 months after birth follow-up

    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.

  6. Next-generation sequencing analysis-based differences on gut microbiota in infants between three groups

    Time frame: 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 collected fecal samples will be analyze the composition of microbiota using NGS method. The differences of microbiota pattern will be identified.

Secondary outcomes

  1. Infantile weight growth between different feeding pattern

    Time frame: The 1 months after birth follow-up

    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.

  2. Infantile weight growth between different feeding pattern

    Time frame: The 2 months after birth follow-up

    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.

  3. Infantile weight growth between different feeding pattern

    Time frame: The 4 months after birth follow-up

    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.

  4. Infantile weight growth between different feeding pattern

    Time frame: The 6 months after birth follow-up

    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.

  5. Infantile weight growth between different feeding pattern

    Time frame: The 12 months after birth follow-up

    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.

  6. Infantile height growth between different feeding pattern

    Time frame: The 1 months after birth follow-up

    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.

  7. Infantile height growth between different feeding pattern

    Time frame: The 2 months after birth follow-up

    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.

  8. Infantile height growth between different feeding pattern

    Time frame: The 4 months after birth follow-up

    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.

  9. Infantile height growth between different feeding pattern

    Time frame: The 6 months after birth follow-up

    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.

  10. Infantile height growth between different feeding pattern

    Time frame: The 12 months after birth follow-up

    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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 15, 2023
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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