Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT00749905
Status:
TERMINATED
Last Update Posted:
2018-06-14
First Post:
2008-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Fiber Diet for Bowel Preparation for Colon Capsule Examination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'whyStopped': 'was not able to recruit enough patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-12', 'studyFirstSubmitDate': '2008-09-08', 'studyFirstSubmitQcDate': '2008-09-08', 'lastUpdatePostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colon cleanliness', 'timeFrame': 'one week from capsule examination'}], 'secondaryOutcomes': [{'measure': 'Tolerability of preparations', 'timeFrame': 'within 1 day of completing preparation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colon Preparation']}, 'descriptionModule': {'briefSummary': 'A prospective randomized controlled investigator-blinded study to compare efficacy of low fiber diet for 5 days versus regular diet, both as adjunct to one day clear liquid diet and standard bowel preparation for colon capsule examination'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 and \\<75\n* Colon study indicated for colo-rectal carcinoma screening\n* After colonoscopy for any indication failed due to technical causes\n* Patients who decline an indicated colonoscopy\n\nExclusion Criteria:\n\n* Significant heart failure (NYHA grade III-IV)\n* Renal failure (Creatinine \\> 1.2 mg/dl)\n* Known or suspected intestinal strictures\n* Known or suspected mesenteric adhesions\n* History suggestive of bowel obstruction\n* Vomiting and/or aspirations\n* Symptoms of dysphagia\n* Pace-maker or AICD implanted\n* Known allergy or intolerance to any of the study drugs\n* Pregnancy\n* Illicit drug abuse or alcoholism\n* Inability to provide an informed consent'}, 'identificationModule': {'nctId': 'NCT00749905', 'briefTitle': 'Low Fiber Diet for Bowel Preparation for Colon Capsule Examination', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'A Prospective Randomized Controlled Investigator-blinded Study of Low Fiber Diet for Bowel Preparation for Colon Capsule Examination', 'orgStudyIdInfo': {'id': 'SHEBA-08-5217-SBH-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Low fiber diet for 5 days prior to procedure', 'interventionNames': ['Other: low fiber diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'regular diet', 'interventionNames': ['Other: regular diet']}], 'interventions': [{'name': 'low fiber diet', 'type': 'OTHER', 'description': 'Low fiber diet for 5 days prior to colon capsule', 'armGroupLabels': ['1']}, {'name': 'regular diet', 'type': 'OTHER', 'description': 'Regular diet until 1 day before colon capsule', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Shomron BenHorin', 'investigatorAffiliation': 'Sheba Medical Center'}}}}