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Nutritional Management of Children With Chronic Diarrhea

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Abbott

Status

Completed

Conditions

Growth and Tolerance Infant Study

Treatments

Other: Experimental Infant Formula

Study type

Interventional

Funder types

Industry

Identifiers

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)

19 participants in 1 patient group

Experimental Infant Formula
Experimental group
Description:
Complete peptide amino acid-based infant formula
Treatment:
Other: Experimental Infant Formula

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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