Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT01191112
Status:
COMPLETED
Last Update Posted:
2015-03-03
First Post:
2010-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-02', 'studyFirstSubmitDate': '2010-08-27', 'studyFirstSubmitQcDate': '2010-08-27', 'lastUpdatePostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stool frequency', 'timeFrame': '14 Days'}, {'measure': 'Frequency and intensity of irritability, vomiting, distension', 'timeFrame': '14 Days'}], 'secondaryOutcomes': [{'measure': 'Average Energy Intake', 'timeFrame': '14 Days'}, {'measure': 'Anthropometrics', 'timeFrame': '14 Days'}, {'measure': 'Medication Use', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Diseases', 'Feeding Intolerance']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the safe use and tolerance of a peptide-based formula in children with gastrointestinal dysfunction and/or feeding intolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or nonpregnant female between 1 and 13 years of age.\n* Subject is diagnosed with gastrointestinal dysfunction and/or feeding intolerance.\n* Subject requires enteral tube feeding as sole source of nutrition.\n\nExclusion Criteria:\n\n* History of diabetes.\n* Requires artificial ventilation.\n* Requires parenteral nutrition.\n* Subject has intestinal obstruction.\n* Subject is receiving dialysis treatment.\n* Subject has an allergy or intolerance to any ingredient in the study product.'}, 'identificationModule': {'nctId': 'NCT01191112', 'briefTitle': 'Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population', 'orgStudyIdInfo': {'id': 'BK87'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peptide Based enteral formula', 'interventionNames': ['Other: Peptide based enteral formula']}], 'interventions': [{'name': 'Peptide based enteral formula', 'type': 'OTHER', 'description': 'Sole source nutrition as per HCP', 'armGroupLabels': ['Peptide Based enteral formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G2J3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': "University of Alberta, Stollery Children's Hospital", 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Jennifer Williams, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}