Nutritional Management of Infants With Chronic Diarrhea
Not Applicable
Completed
- Conditions
- Growth and Tolerance Infant Study
- Interventions
- Other: Experimental Infant Formula
- Registration Number
- NCT01820494
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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
Exclusion Criteria
- Any non-approved concomitant study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Infant Formula Experimental Infant Formula Complete amino acid-based infant formula
- Primary Outcome Measures
Name Time Method Weight Study Day (SD) 1, 28 and 84 Change in weight from baseline.
- Secondary Outcome Measures
Name Time Method Stool Characteristics Study Day (SD) 2-4, 5-7, 25-27 and 81-83 Parent completed diary of stool consistency, frequency/volume.
Trial Locations
- Locations (3)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Children's Hospital of Detroit
🇺🇸Detroit, Michigan, United States
Children's Hospital
🇺🇸Omaha, Nebraska, United States