Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05025267
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2021-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ability to Meet Enteral Nutritional Needs with a Peptide-based, High Protein Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, single-arm, non-randomized, open-label observational study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2021-08-23', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calorie nutritional goals', 'timeFrame': '14 days', 'description': 'Daily percentage of calorie nutritional goals met'}], 'secondaryOutcomes': [{'measure': 'Protein nutritional goals', 'timeFrame': '14 days', 'description': 'Daily percentage of protein nutritional goals met'}, {'measure': 'Daily reports of gastrointestinal intolerance', 'timeFrame': '14 days', 'description': 'Daily occurrence of nausea, stool frequency, stool consistency, and/or vomiting)'}, {'measure': 'Adverse events', 'timeFrame': '14 days', 'description': 'Daily adverse event reporting'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enteral Feeding']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open-label single-arm observational clinical trial to assess enteral feeding nutrition goals with a peptide-based, high protein enteral formula.', 'detailedDescription': 'This is a prospective, observational study to assess the ability to meet enteral nutrition goals and tolerance of a peptide-based, high protein tube feeding product in adult, tube-fed patients living in the community setting. In addition, the study will explore metabolic and inflammatory markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with established enteral access\n* Anticipated to require enteral nutrition to provide 90% or more of their nutritional needs\n* Signed informed consent\n\nExclusion Criteria:\n\n* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)\n* Any condition that would contraindicate use of the study product\n* Patients with active colitis, radiation enteritis, SBS, undergoing active cancer treatment\n* Judged to be at risk for poor compliance to the study protocol\n* Participating in a conflicting clinical trial'}, 'identificationModule': {'nctId': 'NCT05025267', 'briefTitle': 'Ability to Meet Enteral Nutritional Needs with a Peptide-based, High Protein Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Prospective Study of Ability to Meet Nutritional Needs with a Peptide-based, High Protein Enteral Formula', 'orgStudyIdInfo': {'id': '19.01.CA.HCN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Enteral Tube-fed Adults', 'description': 'Adults being fed an enteral formula with a feeding tube', 'interventionNames': ['Other: Medical Food: Peptide-Based Enteral Formula']}], 'interventions': [{'name': 'Medical Food: Peptide-Based Enteral Formula', 'type': 'OTHER', 'description': 'Will be fed exclusively the study peptide-based, high protein enteral formula via a feeding tube', 'armGroupLabels': ['Enteral Tube-fed Adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Krysmaru Araujo Torres, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nestle Health Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}