Status:
COMPLETED
Breastfeeding Study
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Infant Term Birth
Eligibility:
All Genders
21-26 years
Brief Summary
The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy breastfed infants.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 22 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 11 2018
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03387124
Start Date
January 22 2018
End Date
December 11 2018
Last Update
April 24 2019
Active Locations (1)
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1
Asian Hospital and Medical Center
City of Muntinlupa, Alabang, Philippines, 1780