Infant Term Birth
Conditions
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 of defined taxa in 75 healthy, term, exclusively breastfed infants. All enrolled infants will participate in the trial for approximately 169 days.
Interventions
OTHERBreastfed infants
Breastmilk
Sponsors
Société des Produits Nestlé (SPN)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Days to 26 Days
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool Consistency Score | 155 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Microbiota Composition | 155 days | — |
| Changes in Weight from baseline to 155 days | 155 days | weight (kg) |
| Changes in Length from baseline to 155 days | 155 days | length (cm) |
| Changes in Head Circumference from baseline to 155 days | 155 days | head circumference (cm) |
Countries
Philippines
Outcome results
None listed