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Clinical Trials/NCT02028156
NCT02028156TerminatedNot Applicable

Evaluation of Feeding Intolerance in Formula-Fed Infants: A Non-Randomized, Single-Group, Multi-Center Study

Abbott Nutrition3 sites in 1 country3 target enrollmentStarted: January 1, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
3
Locations
3
Primary Endpoint
Improvement in Fussiness
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
— to 60 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Inclusion Criteria for Stage 1:
  • •Singleton full term birth with birth weight of > 2500g.
  • •Infant between 0 and 60 days of age.
  • •Discontinuation of medications that might affect gastrointestinal (GI) tolerance.
  • •Infant is exclusively formula-fed a full-lactose, intact cow milk protein-based infant formula (CMF) for less than 7 days prior to enrollment.
  • •Inclusion Criteria for Stage 2:
  • •Infant was fed according to protocol in Stage 1 of the study.
  • •Infant was identified as being fussy using the Intolerance Assessment Tool in Stage 1.

Exclusion Criteria

  • •Exclusion Criteria for Stage 1:
  • •Chromosomal or major congenital anomalies.
  • •Suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
  • •Hospitalization, other than for delivery, prior to enrollment.
  • •Severe uncontrolled eczema, visible bloody stools or milk protein allergy prior to enrollment.
  • •More than 1 substitution of an infant formula other than full-lactose, intact cow milk formula (CMF) since birth.
  • •Use of a prokinetic drug within 7 days before enrollment.
  • •Exclusion Criteria for Stage 2:
  • •Infant's intolerance symptom was caused by another reason, for example known infection/illness, food allergy, or response to vaccination(s).
  • •Infant has immunization(s) within 3 days of enrollment in Stage 2.

Arms & Interventions

Partially Hydrolyzed Infant Formula

Experimental

Fed ad lib.

Intervention: Partially Hydrolyzed Infant Formula (Other)

Outcomes

Primary Outcomes

Improvement in Fussiness

Time Frame: 0 to 15 days

Study phase 2; Parent completed questionnaire.

Secondary Outcomes

  • Constipation(0 to 4 weeks)
  • Gassiness(0 to 4 weeks)
  • Diarrhea(0 to 4 weeks)
  • Spit-up(0 to 4 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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