Growth and Tolerance Infant Study
Conditions
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.
Interventions
Infant formula to be fed ad libitum
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 9 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician determined target outcome | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Assessment | Study day (SD) 2-4, 5-7, 25-27 and 81-83 | Parent completed record of infant dietary intake. |
| Gastro-Intestinal Tolerance | Study Day (SD) 2-4, 5-7, 25-27, 81-83 | Parent reported record of incidence of regurgitation. |
| Stool characteristics | Study Day (SD) 2-4, 5-7, 25-27 and 81-83 | Parent completed diary of stool consistency, frequency/volume. |
| Blood Chemistry | Study Day (SD) 1 and 84 | Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase |
| Anthropometrics | Study Day (SD) 1, 28 and 84 | Weight and length |
Countries
United States
Outcome results
None listed