Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00742118
Status:
UNKNOWN
Last Update Posted:
2015-09-30
First Post:
2008-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the Enteric Nervous System During the Syndrome of the Irritable Bowel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-29', 'studyFirstSubmitDate': '2008-08-26', 'studyFirstSubmitQcDate': '2008-08-26', 'lastUpdatePostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Para-cellular permeability', 'timeFrame': 'at time=0'}, {'measure': 'Gap junction protein expression', 'timeFrame': 'at time=0'}, {'measure': 'Inflammation molecule expression', 'timeFrame': 'at time=0'}, {'measure': 'Digestive discomfort degree', 'timeFrame': 'at time=0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'Patients with irritable bowel syndrome (IBS) have increased intestinal permeability. In addition, mucosal soluble mediators are involved in the pathophysiology of pain in IBS. The investigators aimed to investigate:\n\n1. paracellular permeability in colonic biopsies of IBS patient\n2. the ability of soluble factors from colonic biopsies to reproduce in vitro these alterations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients needing coloscopy\n\nExclusion Criteria:\n\n* Disrupted coagulation results\n* Cancer even healed\n* Known food allergy.\n* Alcohol consumption \\>30g/day'}, 'identificationModule': {'nctId': 'NCT00742118', 'briefTitle': 'Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the Enteric Nervous System During the Syndrome of the Irritable Bowel', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the entérique Nervous System During the Syndrome of the Irritable Bowel', 'orgStudyIdInfo': {'id': '05-API-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': 'patient with chronic inflammatory intestinal disease', 'interventionNames': ['Procedure: Colic biopsies']}, {'type': 'OTHER', 'label': '3', 'description': 'patient having no symptoms', 'interventionNames': ['Procedure: Colic biopsies']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'patient with irritable bowel syndrome', 'interventionNames': ['Procedure: Colic biopsies']}], 'interventions': [{'name': 'Colic biopsies', 'type': 'PROCEDURE', 'otherNames': ['endoscopic biopsy'], 'description': 'colic biopsies and analysis', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06002', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thierry PICHE, PhD', 'role': 'CONTACT', 'email': 'piche.t@chu-nice.fr'}, {'name': 'Raffaella DAINESE', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of gastroenterology, Hopital Archet 2', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Thierry PICHE, PhD', 'role': 'CONTACT', 'email': 'piche.t@chu-nice.fr'}], 'overallOfficials': [{'name': 'Thierry PICHE, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastroenterology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'collaborators': [{'name': "Fondation de l'Avenir", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}