Nutritional Management of Children With Chronic Diarrhea

Abbott

Status: Completed

Conditions: Growth and Tolerance Infant Study

Treatments: Other: Experimental Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01812629

AH72

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: Under 9 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Experimental Infant Formula

Experimental group

Description:

Complete peptide amino acid-based infant formula

Treatment:

Other: Experimental Infant Formula