Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT06209593
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2024-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability and Tolerance Study of a Plant-based Tube Feed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009748', 'term': 'Nutrition Disorders'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline assessment and daily recording during intervention up to day 7 measuring Gastrointestinal tolerance', 'timeFrame': '7 days', 'description': 'Diarrhoea, constipation, reflux, vomiting, wind, boating'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutrition Disorders']}, 'descriptionModule': {'briefSummary': 'This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 7-day period with a plant based tube feed.', 'detailedDescription': 'Enterally fed adults who are assessed by the Health Care Professional/dietitian as requiring an adult plant- based high-energy, enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the UK Advisory Committee on Borderline Substances (ACBS) for product registration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients established on a tube feed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 16 years and over and adults requiring a plant- based enteral tube feed (taking 50% or more of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition\n* Patients well-established and stable on current polymeric enteral tube feed.\n* Willingly given, written, informed consent from patient\n\nExclusion Criteria:\n\n* Inability to comply with the study protocol, in the opinion of the investigator\n* Under 16 years of age\n* Patients on total parenteral nutrition\n* Known food allergies to any ingredients including patients who have an allergy to milk protein e.g IgE and non- mediated as product contains traces of milk and allergy to peanuts due to the pea protein\n* Patients with significant renal or hepatic impairment\n* Participation in another interventional study within 2 weeks of this study.\n* Patients with known or suspected ileus or mechanical bowel obstruction'}, 'identificationModule': {'nctId': 'NCT06209593', 'briefTitle': 'Acceptability and Tolerance Study of a Plant-based Tube Feed', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Acceptability (including Gastrointestinal Tolerance and Compliance) of a Plant Based High Energy Adult Enteral Formula', 'orgStudyIdInfo': {'id': 'PB 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients well established on tube feeds will act as their own control', 'description': 'Each participant will receive the new trial feed a nutritionally complete standard enteral tube feed for a period of 7 days. The new trial feed is a food for special medical purposes for use under medical supervision. The Health Care Professional/ dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube.', 'interventionNames': ['Dietary Supplement: Compleat plant protein tube feed']}], 'interventions': [{'name': 'Compleat plant protein tube feed', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients on a tube feed will act as their own control and switch to new tube feed.', 'armGroupLabels': ['Patients well established on tube feeds will act as their own control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Nu', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'James Evans', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College London Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Will upload the data as it becomes available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}