Nutritional Management of Children 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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-07-31

Study Completion Date

1999-06-30

Brief Summary

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The study objective is to assess the growth, tolerance and efficacy of a complete amino acid-based medical food in children with 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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Infant Formula

Complete peptide 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 9 months of age at enrollment
* Candidates for an elemental formula
* 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 underlying GI disease with chronic diarrhea controlled by a semi-elemental or elemental formula
* Parents agree to feed infant with experimental formula for least 50% of total calories during study period