The Role of Human Milk Oligosaccharides and Microbiomes on Infantile Colic and Atopic Dermatitis in Term Infants
NCT ID: NCT05992493
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
300 participants
OBSERVATIONAL
2023-08-07
2026-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Breast-milk feeding
Exclusive breastfeeding for 4 months or more
No interventions assigned to this group
Control Formula milk feeding
Exclusive formula milk for 4 months or more
No interventions assigned to this group
HMO-Formula-milk feeding
Exclusive HMO-formula milk for 4 months or more
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Gestational age of \>= 37 weeks
3. birth weight greater than 2500 gm
Exclusion Criteria
2. Mother with antimicrobial agents 1 month before delivery
3. Congenital abnormalities related to growth
4. Major disease admitted to Level II or NICU
1 Day
ALL
Yes
Sponsors
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National Cheng-Kung University Hospital
OTHER
Responsible Party
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Yao-Jong Yang
professor
Locations
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National Cheng Kung University & Hospital
Tainan City, , Taiwan
Countries
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References
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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.
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.
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.
Other Identifiers
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A-BR-109-005
Identifier Type: -
Identifier Source: org_study_id
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