Infant Term Birth
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.
Detailed description
Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.
Interventions
Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum
Standard bovine milk-based term infant formula, fed ad libitum
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Days to 26 Days
Healthy volunteers
Yes
Inclusion criteria
* Written Informed Consent * Infants whose parent(s)/LAR 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 are able to be contacted 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 \>/= - 3 and \</= +3 according to WHO Child Growth Standards * Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment
Exclusion criteria
* Infants with conditions requiring infant feedings other than those specified in the protocol * Infants receiving complementary 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 parents/LAR cannot be expected to comply with the protocol or with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth | 150 days | weight gain velocity |
| Stool Consistency Score | 150 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Microbiota | 150 days | — |
| Weight | 150 days | weight in grams |
| Adverse Events | 150 days | — |
| Fecal Markers | 150 days | — |
| Average Daily Stool Frequency | 150 days | — |
Countries
Philippines
Outcome results
None listed