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Clinical Trials/NCT01155414
NCT01155414CompletedPhase 3

Tolerance of Healthy Term Infants Fed Infant Formulas

Abbott Nutrition19 sites in 1 country168 target enrollmentStarted: March 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
168
Locations
19
Primary Endpoint
GI tolerance via stool consistency
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
1 Day to 8 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Singleton full term birth in good health
  • •Birth weight was > 2490 g.
  • •Between 0 and 8 days of age.
  • •Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to enrollment.
  • •Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
  • •Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.

Exclusion Criteria

  • •An adverse maternal, fetal or infant medical history and treatment with antibiotics

Outcomes

Primary Outcomes

GI tolerance via stool consistency

Time Frame: 28 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (19)

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