Clinical trial NCT03307122: Gastrointestinal Tolerance Evaluation of an Infant Formula
Official title: Infant Formula GI Tolerance Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy, Full-term Infants Who Are Formula-fed
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2017-10-11
Enrollment: 79
Sex: ALL
Minimum age (years): 9
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Infant GI Symptom Burden
timeFrame: 6 weeks
Secondary outcomes:
measure: Stool pattern
timeFrame: 6 weeks
measure: Spit-up and/or vomiting pattern
timeFrame: 6 weeks
measure: Crying and fussing duration
timeFrame: 6 weeks
measure: Formula intake
timeFrame: 6 weeks
measure: Formula satisfaction questionnaire
timeFrame: 6 weeks
measure: Weight (measured in grams)
timeFrame: Enrollment and 6 weeks
measure: Length (measured in centimeters)
timeFrame: Enrollment and 6 weeks
measure: Adverse events
timeFrame: 2 weeks and 6 weeks
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Avanza Medical Research Center
state: Florida
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: Owensboro
country: United States
facility: PediaResearch
state: Kentucky
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Charleston
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: Memphis
country: United States
facility: Midsouth Center for Clinical Research, LLC
state: Tennessee
city: San Antonio
country: United States
facility: Southwest Children's Research Associates
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
Study officials:
affiliation: Nestle Nutrition
name: Ryan Carvalho, MD
role: STUDY_DIRECTOR
References: