Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-26 @ 10:56 PM
Study NCT ID:
NCT02316132
Status:
WITHDRAWN
Last Update Posted:
2022-07-06
First Post:
2014-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Confocal Laser Endomicroscopy, IBS and Stress
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': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No appropriate participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-30', 'studyFirstSubmitDate': '2014-12-05', 'studyFirstSubmitQcDate': '2014-12-09', 'lastUpdatePostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen.', 'timeFrame': 'immediate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': "After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is needed for CLE but is not part of the investigation.\n\nInitial CLE baseline images will be taken to assure intact mucosa and allow later detailed baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal mucosa.\n\nThereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according to randomisation) will be injected intravenously. Endoscopist and assistant staff will be blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5 min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of fluorescein into the gut lumen and widening of intervillous space.\n\nPost procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron microscopy to visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast cell tryptase to identify mast cell activation and numbers.\n\nThe procedure will take around 15 minutes in addition to the routine investigation performed prior to the study. A study outline is presented in figure 1.\n\nSamples taken are the same amount as done in the previous food associated study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>18 years\n* No abdominal symptoms such as bloating and abdominal pain\n* Barrett's esophagus\n* Independent indication for confocal laser endomicroscopy for evaluation of Barrett's dysplasia\n* Written informed consent for participation in this study\n\nExclusion Criteria:\n\n* Any known other gastrointestinal disease including infection such as helicobacter pylori, Morbus Whipple or others, celiac disease, or chronic inflammatory bowel disease\n* Active or recent GI Bleeding\n* Stricture in the upper gastrointestinal tract\n* Impaired renal function (Creatinine \\>1.2 mg/dL)\n* Pregnancy or breast feeding\n* Inability to obtain informed consent\n* Known allergy to Methylene blue or Fluorescein\n* Participation in other clinical trials within the last 4 weeks"}, 'identificationModule': {'nctId': 'NCT02316132', 'briefTitle': 'Confocal Laser Endomicroscopy, IBS and Stress', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Confocal Endomicroscopy for the Detection of Food Intolerances in Patients With IBS: Add on Control Group: Does Stress Cause Similar Mucosal Changes to Food Antigens?', 'orgStudyIdInfo': {'id': 'IBS stress'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stress', 'description': 'Injection of corticotropin releasing factor', 'interventionNames': ['Drug: Stress']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Injection of 0.9% saline 10 ml', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'Stress', 'type': 'DRUG', 'otherNames': ['CRH'], 'description': 'Corticotropin-Releasing Hormone', 'armGroupLabels': ['Stress']}, {'name': 'Control', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Saline 0.9%', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Annette Fritscher-Ravens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Schleswig-Holstein'}, {'name': 'Mark Ellrichmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Schleswig-Holstein'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant, Unit of Experimental Endoscopy', 'investigatorFullName': 'Mark Ellrichmann', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}