Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT02538250
Status:
COMPLETED
Last Update Posted:
2016-10-13
First Post:
2015-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability Study on Oral Nutrition Supplement (ONS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2015-06-24', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events)', 'timeFrame': '7 days', 'description': 'Parameters asked as required for acceptability studies by Advisory Committee for Borderline Substances- documented in a patient diary'}], 'secondaryOutcomes': [{'measure': 'Occurrence of further adverse effects', 'timeFrame': '7 days'}, {'measure': 'Evaluation of palatability by questionnaire', 'timeFrame': '1 day', 'description': 'Five point hedonic scale'}, {'measure': 'Evaluation of compliance.', 'timeFrame': '7 days', 'description': 'Comparison of prescription and actual intake'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oral nutritional supplement', 'supplementation', 'adult patients'], 'conditions': ['Oral Nutritional Supplementation']}, 'descriptionModule': {'briefSummary': 'Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show that it is acceptable for patients in the United Kingdom.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Male and female patients\n* ≥ 18 years of age\n* Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days\n* Patient is able and willing to provide written informed consent\n\nExclusion:\n\n* Hypersensitivity to milk, whey, soy, fish or any of the active substances or excipients\n* Patients with available or potential impairment of sense of taste or smell due to disease (e.g. patients with cold, cancer patients) or medication (e.g. D-Penicillamine)\n* Patients who express general dislike to two or more of the four flavours\n* Severely impaired gastrointestinal function or complete failure\n* Severe metabolic or circulatory disorders\n* Acute disease\n* Unstable vital functions\n* Necessity of total parenteral nutrition or more than 50% Parenteral Nutrition in combined therapy\n* Simultaneous participation in another interventional study\n* Patients who are unwilling or mentally and/or physically unable to adhere to study procedures\n* Pregnancy\n* Emergencies'}, 'identificationModule': {'nctId': 'NCT02538250', 'briefTitle': 'Acceptability Study on Oral Nutrition Supplement (ONS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'Acceptability Study on Nutricomp Drink Plus in Adult Patients', 'orgStudyIdInfo': {'id': 'HC-G-H-1422'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Nutricomp Drink Plus', 'description': 'Nutricomp Drink Plus', 'interventionNames': ['Dietary Supplement: Nutricomp Drink Plus']}], 'interventions': [{'name': 'Nutricomp Drink Plus', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral nutritional supplementation', 'armGroupLabels': ['1 Nutricomp Drink Plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S10 2JF', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals NHS Foundation Trust, The Royal Hallamshire Hospital, Regional Gastrointestinal and Liver Unit', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'David Sanders, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Royal Hallamshire Hospital,Regional Gastrointestinal and Liver Unit, Sheffield, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Medical UK Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}