Nutritional Management of Children With Chronic Diarrhea

March 14, 2013 updated by: Abbott Nutrition

Clinical Management of Children With Chronic Diarrhea

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

- Any non-approved concomitant study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Infant Formula
Complete peptide amino acid-based infant formula
Other: Experimental Infant Formula
Infant formula to be fed ad libitum
Other Names:
  • EleCare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician determined target outcome
Time Frame: Study Day (SD)1-84
Outcome dependent on individual subject assessment and may include decreased stool number, decreased vomiting, decreased gas, weight gain, increased caloric intake, increased protein intake, increased serum albumin concentration, increased hemoglobin concentration, better acceptance of supplemental formula.
Study Day (SD)1-84

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary Assessment
Time Frame: Study day (SD) 2-4, 5-7, 25-27 and 81-83
Parent completed record of infant dietary intake.
Study day (SD) 2-4, 5-7, 25-27 and 81-83
Blood Chemistry
Time Frame: Study Day (SD) 1 and 84
Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase
Study Day (SD) 1 and 84
Gastro-Intestinal Tolerance
Time Frame: Study Day (SD) 2-4, 5-7, 25-27, 81-83
Parent reported record of incidence of regurgitation.
Study Day (SD) 2-4, 5-7, 25-27, 81-83
Stool characteristics
Time Frame: Study Day (SD) 2-4, 5-7, 25-27 and 81-83
Parent completed diary of stool consistency, frequency/volume.
Study Day (SD) 2-4, 5-7, 25-27 and 81-83
Anthropometrics
Time Frame: Study Day (SD) 1, 28 and 84
Weight and length
Study Day (SD) 1, 28 and 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1997

Primary Completion (Actual)

June 1, 1999

Study Completion (Actual)

June 1, 1999

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Estimate)

March 18, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AH72

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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