Status:
COMPLETED
Social and Demographic Determinants of Fatigue in Patients With Inflammatory Bowel Disease in Remission
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Inflammatory Bowel Diseases
Remission
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this observational study is to identify the social and demographic determinants of fatigue in patients with inflammatory bowel disease in remission. Secondly, the objectives of the study a...
Eligibility Criteria
Inclusion
- Patient in clinical remission for at least 6 months:
- for Crohn's disease patients: Harvey Bradshaw Index (HBI) score ≤ 4
- for patients with ulcerative colitis: a partial Mayo score (PMS) ≤ 2 with each subscore of 1 or less)
- Patient in biological remission for at least 6 months fecal calprotectin \<250 μg/g and CRP \<5 mg/
- Documented diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic and histological criteria
- FACIT-F score \< 40 (defining significant fatigue)
- Subjects at least 18 years of age at the time of study inclusion
Exclusion
- Severe acute colitis
- Active infection with HIV, hepatitis B, hepatitis C, or untreated tuberculosis
- Patient(s) objecting to the use of their data for research purposes
Key Trial Info
Start Date :
January 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 24 2024
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT06186999
Start Date
January 17 2024
End Date
June 24 2024
Last Update
April 18 2025
Active Locations (4)
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1
CHU Bordeaux Hôpital Haut Lévêque
Bordeaux, France
2
CHUGA
Grenoble, France
3
Chu Lyon Sud _ Hcl
Lyon, France
4
Chu Montpellier
Montpellier, France