- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01820494
Nutritional Management of Infants With Chronic Diarrhea
March 27, 2013 updated by: Abbott Nutrition
The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Children's Hospital of Detroit
-
-
Nebraska
-
Omaha, Nebraska, United States, 68114
- Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 year (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Any non-approved concomitant study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Infant Formula
Complete amino acid-based infant formula
|
Infant formula to be fed ad libitum
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: Study Day (SD) 1, 28 and 84
|
Change in weight from baseline.
|
Study Day (SD) 1, 28 and 84
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stool Characteristics
Time Frame: Study Day (SD) 2-4, 5-7, 25-27 and 81-83
|
Parent completed diary of stool consistency, frequency/volume.
|
Study Day (SD) 2-4, 5-7, 25-27 and 81-83
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary Assessment
Time Frame: Study day (SD) 2-4, 5-7, 25-27 and 81-83
|
Parent completed record of infant dietary intake.
|
Study day (SD) 2-4, 5-7, 25-27 and 81-83
|
Blood Chemistry
Time Frame: Study Day (SD) 1 and 84
|
Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase
|
Study Day (SD) 1 and 84
|
Physician Assessment of Abdominal Complaints
Time Frame: Study Day (SD) 1, 28 and 84
|
Individualized per subject, may include decreased vomiting, stool number or volume or increased weight gain.
|
Study Day (SD) 1, 28 and 84
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2000
Primary Completion (ACTUAL)
November 1, 2002
Study Completion (ACTUAL)
November 1, 2002
Study Registration Dates
First Submitted
March 26, 2013
First Submitted That Met QC Criteria
March 27, 2013
First Posted (ESTIMATE)
March 28, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
March 28, 2013
Last Update Submitted That Met QC Criteria
March 27, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AJ85
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Growth and Tolerance Infant Study
-
Abbott NutritionCompletedGrowth and Tolerance Infant StudyUnited States
-
DSM Nutritional Products, Inc.AccelovanceCompletedGrowth | Tolerance | Infant DevelopmentUnited States
-
Abbott NutritionCompleted
-
Abbott NutritionCompleted
-
Abbott NutritionCompleted
-
University of British ColumbiaCompletedFocus of Study: Oral Tolerance Test With Glucose, Lactose, SucroseCanada
-
Laboratorios OrdesaUniversidad de GranadaUnknown
-
University of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Colorado... and other collaboratorsCompletedInfant Growth | Infant Gut Microbiome | Infant Body FatUnited States
-
University of ManitobaJohns Hopkins University; University Health Network, Toronto; University of California... and other collaboratorsRecruitingMaternal Health | Infant Growth | Infant NutritionCanada
-
Société des Produits Nestlé (SPN)Completed
Clinical Trials on Experimental Infant Formula
-
Abbott NutritionCompleted
-
Abbott NutritionCompleted
-
Abbott NutritionCompleted
-
Abbott NutritionCompletedGastro-Intestinal ToleranceUnited States
-
Mead Johnson NutritionBeijing Kangchen TechnologiesTerminated
-
Abbott NutritionCompletedInfant DevelopmentUnited States
-
Abbott NutritionCompleted