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Clinical Trials/NCT01813526
NCT01813526CompletedNot Applicable

Evaluation of an Elemental Formula in Infants With Protein Sensitive Colitis

Abbott Nutrition2 sites in 1 country53 target enrollmentStarted: November 1, 1999Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
53
Locations
2
Primary Endpoint
Physician Rated Symptom Score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
Single (Participant)

Eligibility Criteria

Ages
— to 6 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Less than or equal to 6 months of age
  • •36-42 weeks gestational age at birth
  • •Singleton or Twin birth
  • •Diagnosed with protein sensitive colitis
  • •Negative stool culture at time of study entry
  • •No previous history of consuming free amino acid-based medical food
  • •Not receiving cisapride or steroids
  • •No vitamin mineral supplement administration during the study period with the exception of iron or fluoride
  • •No milk or soy products for the duration of the study

Exclusion Criteria

  • Not provided

Arms & Interventions

Experimental Infant Formula

Experimental

Experimental formula to be fed ad libitum.

Intervention: Experimental Infant Formula (Other)

Outcomes

Primary Outcomes

Physician Rated Symptom Score

Time Frame: Study Day (SD) 1 and 43

Calculated from a symptom checklist based on parent report of the previous 7 day history; Change in physician rated symptom score from SD 1 to SD 43.

Secondary Outcomes

  • Mean Rank Stool Consistency(Study Day (SD) 2-4 and 40-42)
  • Weight(Study Day (SD) 1 and 43 Visits)
  • Formula Intake(Study Day (SD) 2-4 and 40-42)
  • Daily Stool Number(Study Day (SD) 2-4 and 40-42)
  • Stool Occult Blood(Study Day (SD) 2-4 and 40-42)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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