Status:
COMPLETED
Nutritional Management of Children With Chronic Diarrhea
Lead Sponsor:
Abbott Nutrition
Conditions:
Growth and Tolerance Infant Study
Eligibility:
All Genders
Up to 9 years
Phase:
NA
Brief Summary
The study objective is to assess the growth, tolerance and efficacy of a complete amino acid-based medical food in children with chronic diarrhea.
Eligibility Criteria
Inclusion
- 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
- \- Any non-approved concomitant study
Key Trial Info
Start Date :
July 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 1999
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01812629
Start Date
July 1 1997
End Date
June 1 1999
Last Update
March 18 2013
Active Locations (2)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287