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Clinical Trials/NCT01573871
NCT01573871CompletedPhase 3

Tolerance and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula

Abbott Nutrition3 sites in 1 country25 target enrollmentStarted: February 1, 2012Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
25
Locations
3
Primary Endpoint
Weight maintenance
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 180 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Infant is 0 to 180 days of age
  • •Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate
  • •Infant has not consumed an extensively hydrolyzed infant formula
  • •Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted
  • •Infant is not receiving steroids.
  • •Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
  • •Parent(s) confirm their intention not to administer solid foods or juices to their infant through the duration of the study.
  • •Parent(s) confirm their intention not to administer vitamin or mineral during the study

Exclusion Criteria

  • •Participation in another study

Arms & Interventions

Hydrolyzed infant formula

Experimental

Hydrolyzed infant formula to be fed ad libitum

Intervention: Experimental Hydrolyzed infant formula (Other)

Outcomes

Primary Outcomes

Weight maintenance

Time Frame: 14 days

Secondary Outcomes

  • Formula volume intake(14 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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