Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT06069167
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2023-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bowel Urgency in Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2023-10-01', 'studyFirstSubmitQcDate': '2023-10-01', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of bowel urgency in a cohort of patients with inflammatory bowel disease', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Inability to defer defecation for more than 15 minutes in patients with inflammatory bowel disease'}], 'secondaryOutcomes': [{'measure': "Prevalence of bowel urgency in a cohort of Crohn's disease patients", 'timeFrame': 'Through study completion, an average of 12 months', 'description': "Inability to defer defecation for more than 15 minutes in patients with Crohn's disease"}, {'measure': 'Prevalence of bowel urgency in a cohort of ulcerative colitis patients', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Inability to defer defecation for more than 15 minutes in patients with ulcerative colitis'}, {'measure': 'Development of the URGENT index (i.e. inflammatory bowel disease-specific bowel urgency index)', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Components of the index based on variables describing in systematic review Caron B et al. Clin Gastroenterol Hepatol. 2023 and IBD expert opinion'}, {'measure': 'To identify IBD-related risk factors associated with an increased risk of bowel urgency', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Inability to defer defecation for more than 15 minutes and potentially predictive factors (i.e. baseline characteristics)'}, {'measure': 'Correlation between the URGENT index and the Urgency Numeric Rating Scale', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Relationships between changes in the URGENT index and changes in the Urgency Numeric Rating Scale'}, {'measure': 'Correlation between the URGENT index and a Global Visual Evaluation', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Relationship between changes in the URGENT index and changes in the Global Visual Evaluation on a 10-point visual analog scale ranging from 0 (minimal activity) to 10 (maximal activity)'}, {'measure': 'Most appropriate definition of bowel urgency for patients with IBD', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'Urgent desire to defecate and/or extreme desire to defecate and/or immediate need to defecate and/or inability to defer defecation for more than 2 minutes and/or inability to defer defecation for more than 5 minutes and/or inability to defer defecation for more than 20 minutes and/or inability to defer defecation for more than 30 minutes and/or having to rush to the toilet and/or not making it to a toilet in time and/or having to stop whatever to have a bowel movement and/or difficult to withstand urge to open bowels and/or running to the bathroom and/or inability to delay bowel movements'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bowel urgency', 'URGENT index', 'IBD', 'UNRS (Urgency Numeric Rating Scale)', 'GVE (Global Visual Evaluation)'], 'conditions': ['Inflammatory Bowel Diseases', 'Crohn Disease', 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': "Bowel urgency is commonly defined as the sudden need to rush to the bathroom to empty one's bowel. In the field of inflammatory bowel disease (IBD) (including Crohn's disease (CD) and ulcerative colitis (UC)), bowel urgency is part of the top five research priorities for future IBD nursing research, and it is a symptom that patients consider to be most important when prioritizing their disease control. Urgency is a patient-reported outcome associated with compromised quality of life and future risk of hospitalizations, corticosteroids, and colectomy in patients with UC.\n\nA meta-analysis of 321 studies examining bowel urgency revealed that only one-third of these clinical studies clearly defined the concept of bowel urgency. Definition of bowel urgency was heterogeneous as 14 different definitions were identified. In most of these studies, non-validated questionnaires were used. They are based on subjective responses of the patients, and they could determine evaluation bias. These data emphasize the lack of standardization in bowel urgency assessment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inflammatory bowel disease patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged at least 18 years old\n* Diagnosis of inflammatory bowel disease according to the European Crohn´s and Colitis Organisation criteria for at least 3 months\n* Person who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data\n* Person affiliated to or beneficiary of a social security plan\n\nExclusion Criteria:\n\n* Person unable to comply with study procedures'}, 'identificationModule': {'nctId': 'NCT06069167', 'acronym': 'URGENT-1', 'briefTitle': 'Bowel Urgency in Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Paris IBD Center'}, 'officialTitle': 'Bowel Urgency in Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'PIBDC-2023-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Collection of data related to bowel urgency', 'type': 'OTHER', 'description': "Data will be extracted from the patient's medical record and patients will be interviewed to collect data specific to the research"}]}, 'contactsLocationsModule': {'locations': [{'zip': '92200', 'city': 'Neuilly-sur-Seine', 'country': 'France', 'facility': 'Institut des MICI', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paris IBD Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}