Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 9:33 PM
Study NCT ID:
NCT06298461
Status:
RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 418}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of bowel cleanliness', 'timeFrame': '1 year', 'description': 'The primary outcome will be adequate quality of bowel cleanliness. Proportion with adequate cleansing will be measured by Boston Bowel Preparation Scale Score ≥2 in all segments.'}, {'measure': 'Quality of bowel cleanliness', 'timeFrame': '1 year', 'description': 'The primary outcome will be adequate quality of bowel cleanliness. Proportion with adequate cleansing will be measured by the Ottawa scale score as a binary adequate/inadequate score (≤7) will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Volume of laxative intake', 'timeFrame': '1 year', 'description': 'Will compare completion of laxative intake.'}, {'measure': 'Endoscopic Outcomes', 'timeFrame': '1 year', 'description': 'Will compare dysplasia detection rate.'}, {'measure': 'Endoscopic Outcomes', 'timeFrame': '1 year', 'description': 'Will compare withdrawal time.'}, {'measure': 'Endoscopic Outcomes', 'timeFrame': '1 year', 'description': 'Will compare total procedure time.'}, {'measure': 'Endoscopic Outcomes', 'timeFrame': '1 year', 'description': 'Will compare cecal intubation rate'}, {'measure': 'Patient experience data', 'timeFrame': '1 year', 'description': 'Will determine the proportion of patients in each group reporting: use of split dose and day before bowel preparation (even though they were prescribed split-dose) , incontinence episodes during bowel preparation and during travel to the colonoscopy appointment; total duration of sleep; number of nocturnal awakenings: patient willingness to repeat colonoscopy using the same preparation; pre-colonoscopy anxiety rating; difficulty with bowel preparation rating. The study specific patient questionnaire will be administered prior to the colonoscopy to avoid any contamination by the experience of the colonoscopy.'}, {'measure': "Crohn's disease or ulcerative colitis flares after colonoscopy", 'timeFrame': 'One month', 'description': 'A one month phone call to determine diagnosed flares within a month'}, {'measure': 'Endoscopic Outcomes', 'timeFrame': '1 year', 'description': 'Will also compare the proportion of patients requiring repeat colonoscopy because of an inadequate bowel preparation. Will collect data on mucosal abnormality suspected by endoscopist to be due to bowel preparation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease', 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Crohn's disease or ulcerative colitis patients scheduled or about to be scheduled for colonoscopy.\n2. Age \\> 18 years\n3. Out-patients\n\nExclusion Criteria:\n\n1. Prior subtotal or total colorectal resection\n2. Contraindications to use of 2L polyethylene glycol (2L-PEG) or Oral Sulfate Solution (OSS): Known renal insufficiency, congestive heart failure, cirrhosis, severe electrolyte imbalance.\n3. Colonoscopy being repeated because of poor preparation in the preceding six months.\n4. Allergies to the employed bowel preparations\n5. Toxic megacolon, ileus, suspected or diagnosed bowel obstruction.\n6. IBD patients thought to be too sick to undergo a full colonoscopy preparation in the opinion of the investigator/treating physician; hospitalized crohn's disease or ulcerative colitis patients.\n7. Pregnancy"}, 'identificationModule': {'nctId': 'NCT06298461', 'briefTitle': "Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.", 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Bowel Preparation for Colonoscopy Among Individuals With IBD: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BowelPrep'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OSS', 'interventionNames': ['Drug: KleanLyte']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2L PEG', 'interventionNames': ['Drug: Bi-PegLyte']}], 'interventions': [{'name': 'KleanLyte', 'type': 'DRUG', 'description': 'Laxative for colonoscopy bowel preparation', 'armGroupLabels': ['OSS']}, {'name': 'Bi-PegLyte', 'type': 'DRUG', 'description': 'Laxative for colonoscopy bowel preparation', 'armGroupLabels': ['2L PEG']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Banke Oketola', 'role': 'CONTACT', 'email': 'adebanke.oketola@umanitoba.ca'}], 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'centralContacts': [{'name': 'Jane Castelli', 'role': 'CONTACT', 'email': 'jcast@mcmaster.ca', 'phone': '289-880-3609'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian IBD Research Consortium (CIRC)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}