Feeding Tolerance Evaluation

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT02405572
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

Crossover study of 2 infant formulas

Detailed Description

Exclusively formula-fed infants will participate in two 2-week feeding periods of 2 infant formulas. Daily tolerance records will be kept by caregivers.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-04-01
• Primary Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Healthy newborn infant
• Full-term (> 37 weeks gestation)
• 0-2 months (birth-56 days) of age on enrollment
• Infant exclusively formula-fed for at least 2 days prior to enrollment
• Having obtained his/her legal representative's informed consent

Exclusion Criteria

• Known or suspected cow-milk allergy
• Congenital illness or malformation
• Significant prenatal and/or postnatal disease
• Currently participating in another clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
stool consistency	2 weeks	caregivers will document on diary records

Secondary Outcome Measures

Name	Time	Method
stool pattern	2 weeks	caregivers will document on diary records
sleep pattern	2 weeks	caregivers will document on diary records
spit-up pattern	2 weeks	caregivers will document on diary records
adverse events	2 weeks	assessed throughout the study
mood	2 weeks	caregivers will document on diary records
formula intake	2 weeks	caregivers will document on diary records

Trial Locations

Locations (2)

Pedia Research; 🇺🇸 Owensboro, Kentucky, United States

Tanner Clinic; 🇺🇸 Layton, Utah, United States