Clinical trial NCT06069167: Bowel Urgency in Inflammatory Bowel Disease
Official title: Bowel Urgency in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Keywords: Bowel urgency
URGENT index
IBD
UNRS (Urgency Numeric Rating Scale)
GVE (Global Visual Evaluation)
Lead sponsor: Paris IBD Center
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inflammatory bowel disease patients

Brief summary: 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.

A 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.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged at least 18 years old
* Diagnosis of inflammatory bowel disease according to the European Crohn´s and Colitis Organisation criteria for at least 3 months
* 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
* Person affiliated to or beneficiary of a social security plan

Exclusion Criteria:

* Person unable to comply with study procedures

Primary outcomes:
measure: Prevalence of bowel urgency in a cohort of patients with inflammatory bowel disease
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
measure: Prevalence of bowel urgency in a cohort of Crohn's disease patients
timeFrame: Through study completion, an average of 12 months
measure: Prevalence of bowel urgency in a cohort of ulcerative colitis patients
timeFrame: Through study completion, an average of 12 months
measure: Development of the URGENT index (i.e. inflammatory bowel disease-specific bowel urgency index)
timeFrame: Through study completion, an average of 12 months
measure: To identify IBD-related risk factors associated with an increased risk of bowel urgency
timeFrame: Through study completion, an average of 12 months
measure: Correlation between the URGENT index and the Urgency Numeric Rating Scale
timeFrame: Through study completion, an average of 12 months
measure: Correlation between the URGENT index and a Global Visual Evaluation
timeFrame: Through study completion, an average of 12 months
measure: Most appropriate definition of bowel urgency for patients with IBD
timeFrame: Through study completion, an average of 12 months
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: Institut des MICI
Study officials:
References: