Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT01347918
Status:
SUSPENDED
Last Update Posted:
2015-04-09
First Post:
2011-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
1H-19F Gastrointestinal MRI in Health and IBS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007618', 'term': 'Karaya Gum'}, {'id': 'C011045', 'term': 'Normacol'}], 'ancestors': [{'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'whyStopped': 'Technical problems', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2011-05-03', 'studyFirstSubmitQcDate': '2011-05-03', 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Small intestinal transit time in minutes', 'timeFrame': 'Regularly over 4 hours'}], 'secondaryOutcomes': [{'measure': 'Small intestinal length and intestinal course', 'timeFrame': 'at 4 hours'}, {'measure': 'Small intestinal motor activity index', 'timeFrame': 'At 4 hours'}, {'measure': 'Small intestinal transport velocity', 'timeFrame': 'Regularly over 4 hours'}, {'measure': 'Local intestinal residence times', 'timeFrame': 'Regularly over 4 hours.'}, {'measure': 'Volume and distribution of intestinal gas', 'timeFrame': 'Regularly over 4 hours.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fluorine MRI, small intestinal transit and motor activity'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to demonstrate and validate the ionizing radiation free and non invasive assessment of small intestinal anatomy, content and function in healthy and disease by a newly developed combined proton (1H) and fluorine (19F) magnetic resonance imaging (MRI) framework. Meal induced and pathology related alterations in small intestinal motor activity, gas distribution and anatomy of healthy volunteers and patients with irritable bowel syndrome (IBS) will be analyzed with this non invasive MRI approach.\n\nThe multinuclear imaging framework consists of a 1H and 19F capable clinical 3T MRI system with standard 1H abdominal surface coils, a dual-channel transmit-receive abdominal 19F surface coil, fluorine labelled impermeable and biocompatible capsules for oral administration (19F capsule) and a 19F projection imaging sequence allowing for the non-invasive detection of the gastrointestinal positions of single and multiple ingested capsules in real time. Dedicated post-processing algorithms are applied to extract parameters of intestinal motor activity from the detected intraluminal capsule movements.\n\nThe proposed unique imaging modality allows for the concurrent, non invasive and repeated analysis of important physiologic parameters of intestinal function together with detailed anatomical information and thus presents an ideal tool for the evaluation of the analyzed parameters as potential biomarkers in IBS.\n\n* Trial with medical device'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The healthy controls will be selected from among students and volunteers that have responded to advertisments in local notice boards of the Zurich University Hospital and the University of Zurich, as well as in an email newsletter ("Mediflash") of the Medical Student Organisation.\n\nThe IBS patients are selected from the patient population seen in the Klinik and Polyklink für Innere Medizin at the University Hopsital Zurich.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy volunteers and IBS patients must fill out the validated Birmingham IBS Symptom Questionnaire\n* Healthy volunteers must be symptom free of any abdominal complaints.\n* IBS patients are defined based on clinical symptoms as described in the Rome III criteria for irritable bowel syndrome:\n\n * Symptoms of recurrent abdominal pain or discomfort and a marked change in bowel habit for at least six months, with symptoms experienced on at least three days of at least three months. Two or more of the following must apply:\n* Pain is relieved by bowel movement\n* Onset of pain is related to a change in frequency of stool\n* Onset of pain is related to a change in the appearance of stool\n* Written informed consent\n\nExclusion criteria:\n\n* Age under 18 or above 65\n* Pathologic underweight or overweight (BMI \\<18 or \\>30kg/m2)\n* Previous history of gastrointestinal disease or surgery (excludes appendectomy, cholecystectomy, hernia repair and anorectal disorders)\n* Previous cardiorespiratory (excludes arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disease, diabetes, drug or alcohol abuse, psychiatric disease\n* Patient unable to stop medication that alters gut function for 72 hours prior to the study, including anticholinergics, prokinetics, proton-pump inhibitors, non-steroidal antiinflammatory drugs\n* Presence of metallic implants, devices or metallic foreign bodies\n* Pregnancy and lactation (female patients of child bearing age will receive a pregnancy test prior to study)\n* Female volunteers without adequate contraception for the duration of the study Involvement in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion\n* Allergy against silicone\n* Claustrophobia'}, 'identificationModule': {'nctId': 'NCT01347918', 'briefTitle': '1H-19F Gastrointestinal MRI in Health and IBS', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Small Intestinal Transit and Motor Function in Health and IBS Patients Studied by Combined 1H and 19F Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'GI-MRI'}, 'secondaryIdInfos': [{'id': '2011-MD-0005', 'type': 'OTHER', 'domain': 'Swissmedic'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'control', 'description': 'Healthy controls', 'interventionNames': ['Device: 19F capsule', 'Dietary Supplement: sterculia']}, {'label': 'IBS', 'description': 'Patients that fulfil the Rome III criteria for irritable bowel syndrome (IBS)', 'interventionNames': ['Device: 19F capsule', 'Dietary Supplement: sterculia']}], 'interventions': [{'name': '19F capsule', 'type': 'DEVICE', 'otherNames': ['fluorine labeled capsule'], 'description': 'Two 19F capsules, one filled with hexafluorobenzene (HFB) and the other filled with perfluoro-15-crown-5-ether (PCE) will be administered orally together with 100 ml of water.', 'armGroupLabels': ['IBS', 'control']}, {'name': 'sterculia', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Normacol'], 'description': '7g of sterculia will be ingested over one week together with the normal breakfast.', 'armGroupLabels': ['IBS', 'control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Gastroenterology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Werner Schwizer, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Gastroenterology & Hepatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}