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The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy breastfed infants.
Condition or disease
Infant Term Birth
Other: Breastfed infants
This is a prospective, observational, non-interventional study. The purpose of this study is to evaluate the stool consistency and variability in fecal microbiota composition, diversity, and abundance of defined taxa in 75 healthy, term, exclusively breastfed infants. All enrolled infants will participate in the trial for approximately 169 days.
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Layout table for eligibility information
Ages Eligible for Study:
up to 26 Days (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
75 healthy term exclusively breastfed infants
Written informed consent
Infants whose parent(s)/LAR who have reached the legal age of majority in the Philippines
Infants whose parent(s)/LAR are willing and able to comply with study requirements
Infants whose parent(s)/LAR who are able to be contacted directly by telephone throughout the study
Healthy term, singleton infant at birth
Between 21 to 26 days post-natal age at enrollment visit
Weight-for-length and head circumference-for-age z-scores are ≥ -3 and ≤ +3 according to WHO Child Growth Standards
Infants of parent(s)/LAR who have previously made the decision to breastfeed their infant at the time of enrollment
Infants with conditions requiring infant feedings other than those specified in the protocol
Infants receiving weaning foods or liquids
Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
Infants who are presently receiving or have received medications that could interfere with the interpretation of study results
Infants or infants whose parent(s)/LAR who cannot be expected to comply with the protocol or with study procedures