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Nutritional Management of Children With Chronic Diarrhea

Primary Purpose

Growth and Tolerance Infant Study

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental Infant Formula
Sponsored by
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth and Tolerance Infant Study

Eligibility Criteria

undefined - 9 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Children's National Medical Center
  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Infant Formula

Arm Description

Complete peptide amino acid-based infant formula

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Dietary Assessment
Parent completed record of infant dietary intake.
Gastro-Intestinal Tolerance
Parent reported record of incidence of regurgitation.
Stool characteristics
Parent completed diary of stool consistency, frequency/volume.
Blood Chemistry
Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase
Anthropometrics
Weight and length

Full Information

First Posted
March 14, 2013
Last Updated
March 14, 2013
Sponsor
Abbott Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT01812629
Brief Title
Nutritional Management of Children With Chronic Diarrhea
Official Title
Clinical Management of Children With Chronic Diarrhea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
June 1999 (Actual)
Study Completion Date
June 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth and Tolerance Infant Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Infant Formula
Arm Type
Experimental
Arm Description
Complete peptide amino acid-based infant formula
Intervention Type
Other
Intervention Name(s)
Experimental Infant Formula
Other Intervention Name(s)
EleCare
Intervention Description
Infant formula to be fed ad libitum
Primary Outcome Measure Information:
Title
Physician determined target outcome
Description
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 Outcome Measure Information:
Title
Dietary Assessment
Description
Parent completed record of infant dietary intake.
Time Frame
Study day (SD) 2-4, 5-7, 25-27 and 81-83
Title
Gastro-Intestinal Tolerance
Description
Parent reported record of incidence of regurgitation.
Time Frame
Study Day (SD) 2-4, 5-7, 25-27, 81-83
Title
Stool characteristics
Description
Parent completed diary of stool consistency, frequency/volume.
Time Frame
Study Day (SD) 2-4, 5-7, 25-27 and 81-83
Title
Blood Chemistry
Description
Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase
Time Frame
Study Day (SD) 1 and 84
Title
Anthropometrics
Description
Weight and length
Time Frame
Study Day (SD) 1, 28 and 84

10. Eligibility

Sex
All
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene Borschel, PhD, RD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24885833
Citation
Borschel MW, Antonson DL, Murray ND, Oliva-Hemker M, Mattis LE, Kerzner B, Tolia V, Baggs G. Two single group, prospective, baseline-controlled feeding studies in infants and children with chronic diarrhea fed a hypoallergenic free amino acid-based formula. BMC Pediatr. 2014 May 29;14:136. doi: 10.1186/1471-2431-14-136.
Results Reference
derived

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Nutritional Management of Children With Chronic Diarrhea

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