Nutritional Management of Children With Chronic Diarrhea

Not Applicable

Completed

• Conditions: Growth and Tolerance Infant Study
• Interventions: Other: Experimental Infant Formula

• Registration Number: NCT01812629
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-07
• Primary Completion: 1999-06
• Study Completion: 1999-06
• Status Verified: 2013-03
• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2013-03-14
• Last Update Submitted: 2013-03-14
• Study First Posted: 2013-03-18
• Last Update Posted: 2013-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Infant Formula	Experimental Infant Formula	Complete peptide amino acid-based infant formula

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Anthropometrics	Study Day (SD) 1, 28 and 84	Weight and length
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

Trial Locations

Locations (2)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States