Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-03-06 @ 12:20 AM
Study NCT ID:
NCT02590120
Status:
COMPLETED
Last Update Posted:
2022-04-15
First Post:
2015-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enteral Nutrition and Amino Acid Absorption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2015-10-27', 'studyFirstSubmitQcDate': '2015-10-27', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amino acid absorption profile', 'timeFrame': '48 hours', 'description': 'Area under the curve of amino acid plasma concentration'}], 'secondaryOutcomes': [{'measure': 'Tolerance', 'timeFrame': '48 hours', 'description': 'Description and occurence of adverse events'}, {'measure': 'Nutritional status', 'timeFrame': '48 hours', 'description': 'Retinol Binding Protein and Transthyretin dosage'}, {'measure': 'Essentials amino acid absorption', 'timeFrame': '48 hours', 'description': 'Area under the curve of plasma concentration'}, {'measure': 'Insulinemia evolution', 'timeFrame': '48 hours', 'description': 'Insulinemia dosage'}, {'measure': 'Link between amino acid and insuline', 'timeFrame': '48 hours', 'description': 'Correlation coefficient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malabsorption']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate amino acid absorption with two different type of proteins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with gastrointestinal disorder : citrulline plasma concentration \\< 20 µmol/L and/or xylose plasma concentration \\< 1,7 mmol/L\n* Patient under enteral nutrition at home\n* Patient already receiving 1 L by day\n\nExclusion Criteria:\n\n* Obese patient BMI \\> 30\n* Diabetes\n* Renal or liver failure\n* Glucocorticoids treatment'}, 'identificationModule': {'nctId': 'NCT02590120', 'acronym': 'PEPS', 'briefTitle': 'Enteral Nutrition and Amino Acid Absorption', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': "Comparaison du Profil d'Absorption Des Acides aminés Entre Une Nutrition entérale Semi-élémentaire et Une Nutrition entérale polymérique", 'orgStudyIdInfo': {'id': '12.02.FR.NHS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enteral nutrition product : product A', 'description': 'Administration during 16 hours.', 'interventionNames': ['Dietary Supplement: Enteral nutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enteral nutrition product : product B', 'description': 'Administration during 16 hours.', 'interventionNames': ['Dietary Supplement: Enteral nutrition']}], 'interventions': [{'name': 'Enteral nutrition', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Enteral nutrition product : product A', 'Enteral nutrition product : product B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Julien Gautry, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nestle Health Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}