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Clinical Trials/NCT02405572
NCT02405572
Completed
Not Applicable

Feeding Tolerance Evaluation

Société des Produits Nestlé (SPN)2 sites in 1 country43 target enrollmentFebruary 2015
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ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Société des Produits Nestlé (SPN)
Enrollment
43
Locations
2
Primary Endpoint
stool consistency
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Société des Produits Nestlé (SPN)
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

stool consistency

Time Frame: 2 weeks

caregivers will document on diary records

Secondary Outcomes

  • formula intake(2 weeks)
  • stool pattern(2 weeks)
  • sleep pattern(2 weeks)
  • spit-up pattern(2 weeks)
  • adverse events(2 weeks)
  • mood(2 weeks)

Study Sites (2)

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