Nutritional Management of Children With Chronic Diarrhea

Abbott Nutrition19 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Growth and Tolerance Infant Study

Interventions

Experimental Infant FormulaOTHER

Infant formula to be fed ad libitum

Eligibility

Sex: ALLMax age: 9 Months

Medical Language ↔ Plain English

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

Locations (2)

Children's National Medical Center

Washington D.C., District of Columbia, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Physician determined target outcome

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.

Time frame: Study Day (SD)1-84

Secondary Outcomes

Dietary Assessment

Parent completed record of infant dietary intake.

Time frame: Study day (SD) 2-4, 5-7, 25-27 and 81-83

Gastro-Intestinal Tolerance

Parent reported record of incidence of regurgitation.

Time frame: Study Day (SD) 2-4, 5-7, 25-27, 81-83

Stool characteristics

Parent completed diary of stool consistency, frequency/volume.

Time frame: Study Day (SD) 2-4, 5-7, 25-27 and 81-83

Blood Chemistry

Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase

Time frame: Study Day (SD) 1 and 84

Anthropometrics

Weight and length

Time frame: Study Day (SD) 1, 28 and 84

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.