Gastrointestinal Tolerance Evaluation of an Infant Formula
- Conditions
- Healthy, Full-term Infants Who Are Formula-fed
- Interventions
- Other: Routine Infant Formula 1Other: Routine Infant Formula 2
- Registration Number
- NCT03307122
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Routine Infant Formula 1 Routine Infant Formula 1 Routine infant formula with probiotic Routine Infant Formula 2 Routine Infant Formula 2 Routine infant formula with probiotic and prebiotic
- Primary Outcome Measures
Name Time Method Infant GI Symptom Burden 6 weeks Study personnel will administer questionnaire
- Secondary Outcome Measures
Name Time Method Adverse events 2 weeks and 6 weeks Assessed throughout study
Length (measured in centimeters) Enrollment and 6 weeks Study personnel will measure
Weight (measured in grams) Enrollment and 6 weeks Study personnel will measure
Spit-up and/or vomiting pattern 6 weeks Caregivers will document on diary records
Formula intake 6 weeks Caregivers will document on diary records
Stool pattern 6 weeks Caregivers will document on diary records
Crying and fussing duration 6 weeks Caregivers will document on diary records
Formula satisfaction questionnaire 6 weeks Study personnel will administer questionnaire
Trial Locations
- Locations (8)
Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
Midsouth Center for Clinical Research, LLC
🇺🇸Memphis, Tennessee, United States
Bluegrass Clinical Research, Inc.
🇺🇸Louisville, Kentucky, United States
PediaResearch
🇺🇸Owensboro, Kentucky, United States
Ohio Pediatric Research Association
🇺🇸Dayton, Ohio, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Coastal Pediatric Associates
🇺🇸Charleston, South Carolina, United States
Southwest Children's Research Associates
🇺🇸San Antonio, Texas, United States