Status:
COMPLETED
Gastrointestinal Tolerance Evaluation of an Infant Formula
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Healthy, Full-term Infants Who Are Formula-fed
Eligibility:
All Genders
9-19 years
Phase:
NA
Brief Summary
Prospective, double-blind, randomized study of 2 infant formulas.
Detailed Description
Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.
Eligibility Criteria
Inclusion
- Healthy newborn singleton infant
- Full-term (\> 37 weeks gestation)
- Birth weight ≥ 2500 grams and ≤ 4500 grams
- 9-19 days of age on enrollment
- Infant's mother has elected not to breastfeed prior to enrollment and infant has exclusively formula-fed for at least 3days prior to enrollment
- Having obtained his/her legal representative's informed consent
Exclusion
- Known or suspected cow-milk allergy
- Currently receiving a specialty infant formula (e.g. extensively hydrolyzed, amino acid-based, metabolic), or soy-based or lactose free infant formula
- Currently not tolerating (as perceived by the caregiver) their formula
- Currently being treated for reflux
- Currently experiencing gastrointestinal or respiratory symptoms secondary to an on-going infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
- Congenital illness or malformation that may affect infant feeding and/or growth
- Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
- Receiving prescription medication (with exception of treatment for thrush or topical medications) or home remedies, herbal preparations, or rehydration fluids that might affect GI tolerance (vitamin and mineral supplements excepted).
- Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen).
- Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.
Key Trial Info
Start Date :
September 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2018
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03307122
Start Date
September 21 2017
End Date
January 19 2018
Last Update
May 23 2018
Active Locations (8)
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1
Avanza Medical Research Center
Pensacola, Florida, United States, 32503
2
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States, 40291
3
PediaResearch
Owensboro, Kentucky, United States, 42310
4
Ohio Pediatric Research Association
Dayton, Ohio, United States, 45414