Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-02-18 @ 1:38 AM
Study NCT ID:
NCT00560157
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2007-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2007-11-06', 'studyFirstSubmitQcDate': '2007-11-16', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of Glutamine after 90 min of enteral product administration', 'timeFrame': 'J5'}], 'secondaryOutcomes': [{'measure': 'Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress', 'timeFrame': 'J1, J5, J8'}, {'measure': 'Tolerance', 'timeFrame': 'Daily until J8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICU patients'], 'conditions': ['Neurological Diseases', 'Pneumopathy', 'Major Abdominal Surgery', 'Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18\\<age\\<89, ASA score\\<4 , SAPS II score\\>10\n* requiring the administration of an exclusive tube feeding nutrition during 7 days and beginning at the latest in the three days following the aggression\n* ICU patients hospitalized for:\n* neurologic affections\n* pneumopathy\n* major abdominal surgery or serious acute pancreatitis\n* written informed consent\n\nExclusion Criteria:\n\n* pregnancy or breast feeding\n* immunosuppressive therapy\n* radiotherapy or chemotherapy in the last six month\n* uncontrolled septic choc\n* auto-immune disease\n* hepatic,renal or digestive insufficiency\n* hyperlipidemia\n* diabetes mellitus type 1\n* digestive malabsorption\n* life threatening situation\n* treatments with growing hormone, glutamine or its metabolites or precursors such as ornithine alpha keto glutarate'}, 'identificationModule': {'nctId': 'NCT00560157', 'briefTitle': 'Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients', 'orgStudyIdInfo': {'id': 'NCNF 0401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'I', 'description': 'Sondalis HP', 'interventionNames': ['Dietary Supplement: Crucial (enteral tube feeding)']}, {'type': 'EXPERIMENTAL', 'label': 'II', 'description': 'Crucial', 'interventionNames': ['Dietary Supplement: Crucial (enteral tube feeding)']}], 'interventions': [{'name': 'Crucial (enteral tube feeding)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Evaluation of new enteral product, Crucial, in ICU patients', 'armGroupLabels': ['I', 'II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92141', 'city': 'Clamart', 'country': 'France', 'facility': 'Hopital A. BECLERE', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Luc CYNOBER, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University PARIS V'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}}}}