Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-01 @ 5:37 PM
Study NCT ID:
NCT01820494
Status:
COMPLETED
Last Update Posted:
2013-03-28
First Post:
2013-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Management of Infants With Chronic Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2002-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-27', 'studyFirstSubmitDate': '2013-03-26', 'studyFirstSubmitQcDate': '2013-03-27', 'lastUpdatePostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dietary Assessment', 'timeFrame': 'Study day (SD) 2-4, 5-7, 25-27 and 81-83', 'description': 'Parent completed record of infant dietary intake.'}, {'measure': 'Blood Chemistry', 'timeFrame': 'Study Day (SD) 1 and 84', 'description': 'Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase'}, {'measure': 'Physician Assessment of Abdominal Complaints', 'timeFrame': 'Study Day (SD) 1, 28 and 84', 'description': 'Individualized per subject, may include decreased vomiting, stool number or volume or increased weight gain.'}], 'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Study Day (SD) 1, 28 and 84', 'description': 'Change in weight from baseline.'}], 'secondaryOutcomes': [{'measure': 'Stool Characteristics', 'timeFrame': 'Study Day (SD) 2-4, 5-7, 25-27 and 81-83', 'description': 'Parent completed diary of stool consistency, frequency/volume.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['growth', 'infants'], 'conditions': ['Growth and Tolerance Infant Study']}, 'referencesModule': {'references': [{'pmid': '33006765', 'type': 'DERIVED', 'citation': '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': '24885833', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Less than or equal to 12 months of age at enrollment\n* Candidates for elemental feeding\n* 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\n* Parents agree to feed infant with experimental formula for least 50% of total calories during study period\n\nExclusion Criteria:\n\n* Any non-approved concomitant study'}, 'identificationModule': {'nctId': 'NCT01820494', 'briefTitle': 'Nutritional Management of Infants With Chronic Diarrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Nutritional Management of Infants With Chronic Diarrhea', 'orgStudyIdInfo': {'id': 'AJ85'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Infant Formula', 'description': 'Complete amino acid-based infant formula', 'interventionNames': ['Other: Experimental Infant Formula']}], 'interventions': [{'name': 'Experimental Infant Formula', 'type': 'OTHER', 'otherNames': ['EleCare'], 'description': 'Infant formula to be fed ad libitum', 'armGroupLabels': ['Experimental Infant Formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Detroit", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': "Children's Hospital", 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Marlene Borschel, PhD, RD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}