Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-09 @ 12:45 AM
Study NCT ID:
NCT02421705
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2013-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99999999}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2099-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2013-07-31', 'studyFirstSubmitQcDate': '2015-04-20', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2099-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)', 'timeFrame': 'at time of investigation (rectal barostat test), Day 1', 'description': 'Visceral sensitivity will me measured by performing a rectal barostat test'}], 'secondaryOutcomes': [{'measure': 'immune activity (measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood)', 'timeFrame': 'at time of investigation (rectal biopsy), Day 1', 'description': 'measuring release of mest cell mediators in rectal biopsies, measuring parameters of immune activity in blood (for example by stimulating Peripheral Blood Mononuclear Cells)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['IBS', 'Ulcerative Colitis, Active', 'Ulcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms)', 'Healthy Controls', "Crohn's Disease, Active", "Crohn's Disease, Remission (6a: With IBS Symptoms, 6b: Without IBS Symptoms)"]}, 'descriptionModule': {'briefSummary': 'Aim:\n\nMore insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.', 'detailedDescription': 'Methods:\n\nSample collection in healthy subjects, IBD and IBS patients:\n\n* biopsy of rectum and colon descendens\n* blood sample collection\n* collection of sample of nasal mucosa\n* feces collection\n* questionnaires\n* rectal barostat sensitivity measurement\n* transit measurement of colon\n* MR scan of brain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor group 1: IBS\n\n1. Irritable Bowel Syndrome (IBS) (ROME III criteria)\n2. No obvious organic explanation for the IBS symptoms\n3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study\n\nGroup 2: active ulcerative colitis 1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy) 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study\n\nGroup 3: ulcerative colitis in remission (3a: with IBS symptoms, 3b: without IBS symptoms)\n\n1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy)\n2. remission is confirmed by at least one sigmoidoscopy\n3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study\n\n Only for group 3a:\n4. Rome III criteria for IBS\n\nGroup 4: Healthy controls No abdominal (pain) complaints.\n\nGroup 5: active Crohn's disease\n\n1\\. diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy) 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study\n\nGroup 6: Crohn's disease in remission (6a: with IBS symptoms, 6b: without IBS symptoms)\n\n1. diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy)\n2. remission is confirmed by at least one sigmoidoscopy\n3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study\n\nExclusion Criteria:\n\nFor all groups:\n\n1. co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting\n2. Abdominal chirurgy (except for an uncomplicated appendectomy)"}, 'identificationModule': {'nctId': 'NCT02421705', 'briefTitle': 'Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Visceral Sensitivity in IBD and IBS: Role of Inflammation, Immune Activity and Genetic Factors', 'orgStudyIdInfo': {'id': 'S51573'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sample collection', 'description': 'Collection of blood, feces samples, sample of nasal mucosa and biopsies (rectum and colon descendens), questionnaires and performance of rectal sensitivity measurement (barostat), MR scan of brain and transit measurement of colon', 'interventionNames': ['Other: Sample collection']}], 'interventions': [{'name': 'Sample collection', 'type': 'OTHER', 'description': 'Collection of blood, feces samples, sample of nasal mucosa and biopsies (rectum and colon descendens), questionnaires and performance of rectal sensitivity measurement (barostat), MR scan of brain and transit measurement of colon', 'armGroupLabels': ['Sample collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Lien Beullens, MSc', 'role': 'CONTACT', 'email': 'lien.beullens@kuleuven.be', 'phone': '0032-16-341943'}, {'name': 'Dafne Balemans, MSc', 'role': 'CONTACT', 'email': 'dafne.balemans@med.kuleuven.be', 'phone': '0032-16-330158'}], 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Koen Bellens, MSc', 'role': 'CONTACT', 'email': 'koen.bellens@kuleuven.be', 'phone': '0032-16-341943'}], 'overallOfficials': [{'name': 'Guy Boeckxstaens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University Leuven and Universitary Hospitals Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Guy Boeckxstaens', 'investigatorAffiliation': 'KU Leuven'}}}}