Status:
COMPLETED
Nutritional Management of Infants With Chronic Diarrhea
Lead Sponsor:
Abbott Nutrition
Conditions:
Growth and Tolerance Infant Study
Eligibility:
All Genders
Up to 12 years
Phase:
NA
Brief Summary
The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Any non-approved concomitant study
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2002
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01820494
Start Date
October 1 2000
End Date
November 1 2002
Last Update
March 28 2013
Active Locations (3)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Children's Hospital of Detroit
Detroit, Michigan, United States, 48201
3
Children's Hospital
Omaha, Nebraska, United States, 68114