Nutritional Management of Infants With Chronic Diarrhea
1 other identifier
interventional
27
1 country
3
Brief Summary
The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of 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 Oct 2000
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 26, 2013
CompletedFirst Posted
Study publicly available on registry
March 28, 2013
CompletedMarch 28, 2013
March 1, 2013
2.1 years
March 26, 2013
March 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight
Change in weight from baseline.
Study Day (SD) 1, 28 and 84
Secondary Outcomes (1)
Stool Characteristics
Study Day (SD) 2-4, 5-7, 25-27 and 81-83
Other Outcomes (3)
Dietary Assessment
Study day (SD) 2-4, 5-7, 25-27 and 81-83
Blood Chemistry
Study Day (SD) 1 and 84
Physician Assessment of Abdominal Complaints
Study Day (SD) 1, 28 and 84
Study Arms (1)
Experimental Infant Formula
EXPERIMENTALComplete amino acid-based infant formula
Interventions
Infant formula to be fed ad libitum
Eligibility Criteria
You may qualify if:
- Less than or equal to 12 months of age at enrollment
- Candidates for elemental feeding
- 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 GI disease requiring an elemental diet or have underlying GI disease without chronic diarrhea if his/her chronic diarrhea is controlled or is in remission by a semi-elemental or elemental formula for no more than 13 weeks
- 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 (3)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Children's Hospital of Detroit
Detroit, Michigan, 48201, United States
Children's Hospital
Omaha, Nebraska, 68114, United States
Related Publications (2)
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PMID: 33006765DERIVEDBorschel 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
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2013
First Posted
March 28, 2013
Study Start
October 1, 2000
Primary Completion
November 1, 2002
Study Completion
November 1, 2002
Last Updated
March 28, 2013
Record last verified: 2013-03