Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-29 @ 6:57 AM
Study NCT ID:
NCT02271802
Status:
COMPLETED
Last Update Posted:
2014-10-22
First Post:
2014-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Butyrate Enema on the Systemic Concentration of Short Chain Fatty Acids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020148', 'term': 'Butyric Acid'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-21', 'studyFirstSubmitDate': '2014-10-20', 'studyFirstSubmitQcDate': '2014-10-21', 'lastUpdatePostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma SCFAs', 'timeFrame': '0, 5, 15, 30 min after administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Butyrate', 'Interorgan metabolism', 'Short-chain fatty acids', 'Gut production'], 'conditions': ['SCFA Metabolism']}, 'referencesModule': {'references': [{'pmid': '26156796', 'type': 'DERIVED', 'citation': 'van der Beek CM, Bloemen JG, van den Broek MA, Lenaerts K, Venema K, Buurman WA, Dejong CH. Hepatic Uptake of Rectally Administered Butyrate Prevents an Increase in Systemic Butyrate Concentrations in Humans. J Nutr. 2015 Sep;145(9):2019-24. doi: 10.3945/jn.115.211193. Epub 2015 Jul 8.'}]}, 'descriptionModule': {'briefSummary': 'In this placebo-controlled randomized parallel study the effects of a butyrate enema on plasma short-chain fatty acids (SCFA) concentrations and fluxes from portal drained viscera, liver and the splanchnic area are investigated', 'detailedDescription': 'Patients undergoing upper abdominal surgery are included. During surgery they receive a butyrate enema or placebo enema. Before and after rectal administration, plasma samples are taken from several veins and arteries to analyse SCFA concentrations and fluxes from portal drained viscera, liver and the splanchnic area.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing open liver resection or pancreaticoduodenectomy\n\nExclusion Criteria:\n\n* known parenchymal liver disease\n* presence of ileostomy or colostomy\n* patients with inflammatory bowel disease\n* antibiotics, prebiotics or probiotics 2 months prior to surgery'}, 'identificationModule': {'nctId': 'NCT02271802', 'briefTitle': 'Effect of a Butyrate Enema on the Systemic Concentration of Short Chain Fatty Acids', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Effect of a Butyrate Enema on the Systemic Concentration of Short Chain Fatty Acids', 'orgStudyIdInfo': {'id': 'METC 08-2-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Butyrate', 'description': 'Enema containing sodium butyrate', 'interventionNames': ['Dietary Supplement: Sodium butyrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Enema containing NaCl', 'interventionNames': ['Dietary Supplement: NaCl']}], 'interventions': [{'name': 'Sodium butyrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients recieved an enema containing butyrate or a placebo during upper abdominal surgery.', 'armGroupLabels': ['Butyrate']}, {'name': 'NaCl', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229ER', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'CHC Dejong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Top Institute Food and Nutrition', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}