Gastrointestinal Tolerance Evaluation of an Infant Formula

Nestlé

Status

Completed

Conditions

Healthy, Full-term Infants Who Are Formula-fed

Treatments

Other: Routine Infant Formula 1

Other: Routine Infant Formula 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT03307122

17.01.US.INF

Details and patient eligibility

About

Prospective, double-blind, randomized study of 2 infant formulas.

Full 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.

Enrollment

79 patients

Sex

All

Ages

9 to 19 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.