Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT06102135
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2023-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acceptability and Tolerance Study of Peptide Feed with Fibre
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2023-08-22', 'studyFirstSubmitQcDate': '2023-10-20', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess tolerance via patient diaries', 'timeFrame': '14 days', 'description': 'Daily assessment of diarrhoea, constipation, reflux, vomiting, wind, bloating'}, {'measure': 'Daily formula intake', 'timeFrame': '14 days', 'description': 'mL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Exposure']}, 'descriptionModule': {'briefSummary': 'Enterally fed adults with documented evidence of gastrointestinal intolerance will be recruited. Participants will be deemed by the investigator as having a clinical indication for enteral feeding with a fibre containing peptide formula. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.', 'detailedDescription': 'To evaluate the acceptability (including gastrointestinal tolerance and compliance) of an adult enteral peptide formula containing Partially Hydrolysed Guar Gum (PHGG) fibre in 15 patients. This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a fourteen-day period. Data will be collected using patient diaries to asses changes in GI tolerance and tube feed intake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enterally fed adults feeding taking ≥60% of nutritional requirements from enteral nutrition\n\n * Patients with documented evidence of feeding intolerance or GI symptoms during enteral feeding, and who in the clinical judgement of the supervising dietitian may benefit from a peptide formula with fibre.\n * Aged 18 years and above.\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\n * Patients receiving mechanical ventilation, sedation or inotropic support\n * Patients on total parenteral nutrition\n * Known food allergies to any ingredients (see ingredients list) or galactosaemia\n * Patients with significant renal or hepatic impairment\n * Patients with planned changes to medication or treatments during the study period which may alter gastrointestinal function (e.g. chemotherapy). Changes in medications or nutritional products during the study intervention must be documented.\n * Participation in another interventional study within 2 weeks of this study.\n * Patients with a clinical indication for a low fibre or fibre free diet as advised by the healthcare team.\n * Patients with known or suspected ileus or mechanical bowel obstruction.'}, 'identificationModule': {'nctId': 'NCT06102135', 'briefTitle': 'Acceptability and Tolerance Study of Peptide Feed with Fibre', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'To Evaluate the Acceptability (including Gastrointestinal Tolerance and Compliance) of an Adult Peptide 1.3 Kcal/ml Tube-feed Formula Containing Partially Hydrolysed Guar Gum (PHGG) Fibre.', 'orgStudyIdInfo': {'id': 'Peptide 003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients well established on tube feeds will act as their own control', 'description': 'Patients in the control group will switch from current feed to new tube feed to assess tolerance and acceptability.', 'interventionNames': ['Dietary Supplement: Peptamen 1.3 PHGG']}], 'interventions': [{'name': 'Peptamen 1.3 PHGG', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The amount of tube feed will be assess by the health Care Professional.', 'armGroupLabels': ['Patients well established on tube feeds will act as their own control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Nutrition and Dietetics', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Nutrition and Dietetics', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}], 'overallOfficials': [{'name': 'Stephanie Wakefield', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Newcastle Upon Tyne Hospital Trust'}, {'name': 'Nirouz Zarroug', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liverpool university Hospital Trust'}]}, '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'}}}}