Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT07210658
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Children will act as their own control.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal tolerance', 'timeFrame': 'Days 1-7, and at day 14, 21 and 28', 'description': 'Number of children who experienced gastrointestinal symptoms such as reflux, vomiting, nausea, constipation, diarrhoea recorded as a 4 point Likert scale as none, mild, moderate, severe symptoms at baseline and at post switch.'}], 'secondaryOutcomes': [{'measure': 'Formula intake in mLs', 'timeFrame': '28 days', 'description': 'The amount of mLs of formula intake by patient compared to what was prescribed in mLs.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acceptability'], 'conditions': ['Paediatrics']}, 'descriptionModule': {'briefSummary': 'Acceptability, compliance and palatability study.', 'detailedDescription': 'Acceptability (including gastrointestinal tolerance, compliance and palatability) of a paediatric oral nutritional supplement containing food blends.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients from 1-15 years requiring 1 or more oral nutritional supplement to replace current oral nutritional supplement as part of their dietary management for disease related malnutrition.\n* Patients well-established and stable on current nutritional support regimen.\n* Willingly given, written, informed consent from patient/caregiver.\n\nExclusion Criteria:\n\n* Unsafe swallow\n* Inability to comply with the study protocol, in the opinion of the investigator.\n* Under 1 years of age\n* Patients on total parenteral nutrition\n* Known food allergies, including any allergies to the ingredients\n* Patients with Chronic Kidney Disease (CKD) stage 3b (G3b), stage 4 (G4), stage 5 (G5) 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': 'NCT07210658', 'briefTitle': 'Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Acceptability (Including Gastrointestinal Tolerance, Compliance and Palatability) of a Paediatric Oral Nutritional Supplement Containing Food Blends.', 'orgStudyIdInfo': {'id': 'ONS FB 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Children will act as their own control for the nutritional product', 'interventionNames': ['Dietary Supplement: Oral nutritional supplementation']}], 'interventions': [{'name': 'Oral nutritional supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'As directed by the HCP', 'armGroupLabels': ['Children will act as their own control for the nutritional product']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Nutrition and Dietetics', 'role': 'CONTACT', 'email': 's.durnan@nhs.net'}], 'facility': 'Dietetics', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'centralContacts': [{'name': 'Sharan Saduera, BSc (Hons) Dietetics', 'role': 'CONTACT', 'email': 'sharan.saduera@uk.nestle.com', 'phone': '+447557170649'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}