Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
Study NCT ID:
NCT00345566
Status:
UNKNOWN
Last Update Posted:
2006-06-28
First Post:
2006-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Protein Composition on Gastric Emptying
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2007-12'}, 'lastUpdateSubmitDate': '2006-06-27', 'studyFirstSubmitDate': '2006-06-27', 'studyFirstSubmitQcDate': '2006-06-27', 'lastUpdatePostDateStruct': {'date': '2006-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric emptying, measured by octanoic acid breath test.'}], 'secondaryOutcomes': [{'measure': 'Electrogastrography'}]}, 'conditionsModule': {'keywords': ['cerebral palsy', 'protein composition', 'gastric emptying rate', 'tube feeding'], 'conditions': ['Cerebral Palsy', 'Gastric Dysmotility', 'Enteral Feeding']}, 'referencesModule': {'references': [{'pmid': '23196118', 'type': 'DERIVED', 'citation': 'Brun AC, Stordal K, Johannesdottir GB, Fossum V, Bentsen BS, Medhus AW. Nissen fundoplication in children with cerebral palsy: influence on rate of gastric emptying and postprandial symptoms in relation to protein source in caloric liquid meals. Clin Nutr. 2013 Aug;32(4):619-23. doi: 10.1016/j.clnu.2012.11.010. Epub 2012 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'The protein composition of nutrition may affect the rate of gastric emptying and gastric fysiology. This is espesially important in children with neurologic impariment, who commonly rely on tube feedings, have feeding problems, nausea, vomiting, gastroesophageal reflux and delayed gastric emptying. We aim to find out whether 4 different protein sources affect the rate of gastric emptying and electrofysiology in this group of children.', 'detailedDescription': 'Several factors in nutrition are known to affect gastric emptying rate, such as energy content, temperature, viscosity etc. In infants the protein composition affects gastric emptying. Children with cerebral pasly commonly have foregut dysmotility - with nausea, vomiting, feeding intolerance and gastroesophageal reflux. Tube feedings, usually based on cows milk are commonly used.\n\nOur hypothesis is that the source and thus protein composition of feeding affects gastric emptying rate and electrofysiology.\n\nUsing four different tube feedings, standardized for content of fat, glucose and calories, we will measure gastric emptying rate using C13 octanoic acid as well as electrogastrography will be recorded. The protein modules are derived from casein, whey/casein mixture, hydrolyzed whey and aminoacids. Children with cerebral paresis and gastrostomy will be included. Each serves as his / her own control.\n\nThe primary endpoint is gastric emptying rate, the secondary endpoint electrogastrography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Cerebral paresis, user of tube feedings through gastrostomy -\n\nExclusion Criteria: Use of valproic acid (interferes with breath test). Age \\>16 y.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00345566', 'briefTitle': 'Effect of Protein Composition on Gastric Emptying', 'organization': {'class': 'OTHER', 'fullName': 'Ullevaal University Hospital'}, 'officialTitle': 'Effect of the Protein Composition on the Gastric Emptying Rate in Children With Cerebral Paresis', 'orgStudyIdInfo': {'id': 'UUSKBK28200706'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nutrition composition', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Ullevaal university hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Groa B Johannesdottir, MD', 'role': 'CONTACT', 'email': 'groh@uus.no', 'phone': '004722118765'}, {'name': 'Charlotte Brun, MD', 'role': 'CONTACT', 'email': 'brap@uus.no', 'phone': '004722118765'}], 'overallOfficials': [{'name': 'Ketil Stordal, PHD', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Numico Europe', 'class': 'UNKNOWN'}]}}}