Nutritional Management of Infants With Chronic Diarrhea

Abbott

Status: Completed

Conditions: Growth and Tolerance Infant Study

Treatments: Other: Experimental Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01820494

AJ85

Details and patient eligibility

About

The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.

Enrollment: 27 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

27 participants in 1 patient group

Experimental Infant Formula

Experimental group

Description:

Complete amino acid-based infant formula

Treatment:

Other: Experimental Infant Formula