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NCT06069167Completed

Bowel Urgency in Inflammatory Bowel Disease

Source: ClinicalTrials.gov · Last updated 26 Mar 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
1000 (actual)
First submitted
1 Oct 2023
Start date
12 Oct 2023
Primary completion date
22 Mar 2024
Lead sponsor
Paris IBD Center
NCT number
NCT06069167

What you commit to

  • Study type: Observational
  • Participants enrolled: 1000
  • From 12 Oct 2023 to the primary completion date, 22 Mar 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Person unable to comply with study procedures

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut des MICI
Coordinator of this site? Confirm its status
Neuilly-sur-SeineFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.