Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-09 @ 5:50 AM
Study NCT ID:
NCT05838495
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2023-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Tolerance and Safety of a Tube Feeding Formula in Children
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': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2023-04-05', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutritional efficacy - energy', 'timeFrame': '14 days', 'description': 'Percent of daily calorie nutritional goals met'}], 'secondaryOutcomes': [{'measure': 'Nutritional efficacy - protein', 'timeFrame': '14 days', 'description': 'Percent of daily protein nutritional goals met'}, {'measure': 'Frequency of nausea', 'timeFrame': '14 days', 'description': 'Daily frequency of nausea for each participant'}, {'measure': 'Frequency of vomiting', 'timeFrame': '14 days', 'description': 'Daily frequency of vomiting for each participant'}, {'measure': 'Bristol Stool Chart', 'timeFrame': '14 days', 'description': 'Daily reporting of stool parameters using Bristol stool chart. Scale from 1-7. Type 1: Separate hard lumps (hard to pass) Type 2: Lumpy, hard, sausage-shaped Type 3: Sausage-shaped with cracks on the surface Type 4: Sausage-shaped or snake-like; smooth and soft Type 5: Soft blobs with clear-cut edges (easy to pass) Type 6: Fluffy pieces with ragged edges; mushy Type 7: Entirely liquid, watery, no solid pieces'}, {'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': 'To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.', 'detailedDescription': 'The purpose of this study is to assess the efficacy (ability to meet prescribed calorie and protein needs), tolerance, and safety of a pediatric enteral formula (i.e., the study product) in participants aged 1-13 years for 14 days of use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically stable, enterally tube-fed children\n* Aged 1 to 13 years (inclusive) at the time of screening.\n* Currently tolerating enteral feeding and should be appropriate for study formula\n* Requires enteral tube feeding to provide 90% or more of their nutritional needs\n* signed informed consent\n\nExclusion Criteria:\n\n* Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).\n* Currently using or has previously used the study product\n* Any medical condition or contraindicated medications that would contraindicate use of the study product\n* Any illness within \\~5-7 days of screening and/or baseline lasting \\>48 hours and assessed by the PI to have affected nutritional intake on a case-by-case basis.\n* Participation in another interventional clinical study\n* Any condition or abnormality that, in the opinion of the PI, would compromise the safety of the participant or the quality of the study data.'}, 'identificationModule': {'nctId': 'NCT05838495', 'briefTitle': 'Nutritional Tolerance and Safety of a Tube Feeding Formula in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'A Single-center, Open-label Study on the Nutritional Adequacy, Tolerability, and Safety of a Hypercaloric, Plant-based, Real Food Ingredient Formula for Tube Fed Pediatric Patients', 'orgStudyIdInfo': {'id': 'N02-20-01-T0004'}, 'secondaryIdInfos': [{'id': '22.01.CA.HCN', 'type': 'OTHER', 'domain': 'Sponsor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enteral tube fed children', 'description': 'Children being fed an enteral formula with a feeding tube', 'interventionNames': ['Other: formulated liquid diet']}], 'interventions': [{'name': 'formulated liquid diet', 'type': 'OTHER', 'description': 'will be fed exclusively the pediatric enteral study formula with a feeding tube', 'armGroupLabels': ['Enteral tube fed children']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jessie Hulst, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}, {'name': 'Cindy Steel, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Nestle Health Science Canada'}, {'name': 'Krys Araujo Torres, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nestle Health Science USA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}