Clinical trial NCT05992493: The Role of Human Milk Oligosaccharides and Microbiomes on Infantile Colic and Atopic Dermatitis in Term Infants
Official title: To Explore and Develop the Effective Human Milk Oligosaccharides and Microbiomes on Maternal and Infant Health and Neurodevelopment in Early Infancy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Infantile Colic
Breast Feeding
Atopic Dermatitis
Infant Formula
Keywords: Breast milk
microbiota
infant health
Human milk oligosaccharides
prebiotics
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of IC and AD will be compared between three groups
timeFrame: The 1 months after birth follow-up
measure: Incidence of IC and AD will be compared between three groups
timeFrame: The 2 months after birth follow-up
measure: Incidence of IC and AD will be compared between three groups
timeFrame: The 4 months after birth follow-up
measure: Incidence of IC and AD will be compared between three groups
timeFrame: The 6 months after birth follow-up
measure: Incidence of IC and AD will be compared between three groups
timeFrame: The 12 months after birth follow-up
measure: Next-generation sequencing analysis-based differences on gut microbiota in infants between three groups
timeFrame: Infant stool samples will be collected at various time points from 0 to 1 year of age.
Secondary outcomes:
measure: Infantile weight growth between different feeding pattern
timeFrame: The 1 months after birth follow-up
measure: Infantile weight growth between different feeding pattern
timeFrame: The 2 months after birth follow-up
measure: Infantile weight growth between different feeding pattern
timeFrame: The 4 months after birth follow-up
measure: Infantile weight growth between different feeding pattern
timeFrame: The 6 months after birth follow-up
measure: Infantile weight growth between different feeding pattern
timeFrame: The 12 months after birth follow-up
measure: Infantile height growth between different feeding pattern
timeFrame: The 1 months after birth follow-up
measure: Infantile height growth between different feeding pattern
timeFrame: The 2 months after birth follow-up
measure: Infantile height growth between different feeding pattern
timeFrame: The 4 months after birth follow-up
measure: Infantile height growth between different feeding pattern
timeFrame: The 6 months after birth follow-up
measure: Infantile height growth between different feeding pattern
timeFrame: The 12 months after birth follow-up
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University & Hospital
Study officials:
References:
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.
citation: 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.
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.