Nutritional Management of Infants With Chronic Diarrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2002-11-30

Brief Summary

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The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.

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Detailed Description

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Conditions

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Growth and Tolerance Infant Study

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Experimental Infant Formula

Complete amino acid-based infant formula

Group Type EXPERIMENTAL

Experimental Infant Formula

Intervention Type OTHER

Infant formula to be fed ad libitum

Interventions

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Experimental Infant Formula

Infant formula to be fed ad libitum

Intervention Type OTHER

Other Intervention Names

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EleCare

Eligibility Criteria

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Inclusion Criteria

* Less than or equal to 12 months of age at enrollment
* Candidates for elemental feeding
* Chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, HIV-advanced disease or other GI disease requiring an elemental diet or have underlying GI disease without chronic diarrhea if his/her chronic diarrhea is controlled or is in remission by a semi-elemental or elemental formula for no more than 13 weeks
* Parents agree to feed infant with experimental formula for least 50% of total calories during study period