Nutritional Management of Children With Chronic Diarrhea
Clinical Management of Children With Chronic Diarrhea
1 other identifier
interventional
19
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 1997
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 1999
CompletedFirst Submitted
Initial submission to the registry
March 14, 2013
CompletedFirst Posted
Study publicly available on registry
March 18, 2013
CompletedMarch 18, 2013
March 1, 2013
1.9 years
March 14, 2013
March 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Day (SD)1-84
Secondary Outcomes (5)
Dietary Assessment
Study day (SD) 2-4, 5-7, 25-27 and 81-83
Gastro-Intestinal Tolerance
Study Day (SD) 2-4, 5-7, 25-27, 81-83
Stool characteristics
Study Day (SD) 2-4, 5-7, 25-27 and 81-83
Blood Chemistry
Study Day (SD) 1 and 84
Anthropometrics
Study Day (SD) 1, 28 and 84
Study Arms (1)
Experimental Infant Formula
EXPERIMENTALComplete peptide amino acid-based infant formula
Interventions
Infant formula to be fed ad libitum
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Any non-approved concomitant study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (2)
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Related Publications (1)
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.
PMID: 24885833DERIVED
Study Officials
- STUDY CHAIR
Marlene Borschel, PhD, RD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2013
First Posted
March 18, 2013
Study Start
July 1, 1997
Primary Completion
June 1, 1999
Study Completion
June 1, 1999
Last Updated
March 18, 2013
Record last verified: 2013-03