Gastrointestinal Tolerance Evaluation of an Infant Formula

Completed · Not applicable

Conditions studied: Healthy, Full-term Infants Who Are Formula-fed

In brief

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

Key facts

Study ID

NCT03307122

Run by

Société des Produits Nestlé (SPN)

People needed

79

Starts

2017-09-21

Expected to finish

2018-01-19

Last updated by the study team

2018-05-23

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Avanza Medical Research Center — Pensacola, Florida, United States
• Bluegrass Clinical Research, Inc. — Louisville, Kentucky, United States
• PediaResearch — Owensboro, Kentucky, United States
• Ohio Pediatric Research Association — Dayton, Ohio, United States
• Coastal Pediatric Associates — Charleston, South Carolina, United States
• Midsouth Center for Clinical Research, LLC — Memphis, Tennessee, United States
• Southwest Children's Research Associates — San Antonio, Texas, United States
• Tanner Clinic — Layton, Utah, United States

Full record on ClinicalTrials.gov

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