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Mechanism of Chronic Pain in Patients With IBD
Sponsor: Queen Mary University of London
Summary
Abdominal pain is a common symptom in patients with inflammatory bowel disease (IBD). Up to 70 % of IBD patients experience pain when the disease is active. Even when patients with IBD are in remission, 20-50 % experience ongoing pain. The precise mechanism of developing chronic abdominal pain in patients with IBD in remission remains unknown. The aim of this study is to identify psychophysiological and biological risk factors for the development of chronic abdominal pain in patients with newly diagnosed IBD (ulcerative colitis and Crohn's disease). This study consists of 4 sections (Study 1A, 1B, 2, and 3): Study 1A: We perform a longitudinal study in 150 patients with new-onset IBD over 18 months to identify risk factors related to the brain-gut axis for the development of chronic pain. This is a collaborative study with IBD BioResourse Inception study. We administer online questionnaires, collect stool and blood samples, and record heart rate. Other physiological data collected by the Inception study will be also used for the analysis. Study 1B: This is also a collaborative study with the Inception study. We will apply for our detailed questionnaires for 7 days (as per study 1A) to be administered to all the new patients (n=450) that are included in the Inception study on a voluntary basis. Patients will be followed for 12 months. Study 2 and 3: Study 2 and 3 are a questionnaire-based cross-sectional study in patients with IBD. The participants for study 2 are patients registered in IBD BOOST study and those for study 3 are patients registered in IBD BioResource (but not in IBD Boost study). Detailed online questionnaires will be administered to them. These studies are just one-day assessment.
Official title: Psychophysiological and Biological Profiling of Chronic Pain in Patients With Inflammatory Bowel Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
25600
Start Date
2021-07-26
Completion Date
2025-12-31
Last Updated
2025-07-24
Healthy Volunteers
No
Conditions
Interventions
Assessment of Psychophysiological factors
Investigating the presence of psychophysiological factors (depression, anxiety, catastrophizing) by questionnaires.
Assessment of Biological factors
Investigating autonomic nervous function using heart rate recording, colon biopsy samples, microbiota, and blood cytokines levels. (Colon biopsy samples are obtained when colonoscopy is performed for clinical reasons. Blood samples and stool samples will be taken when participants come to the hospital for colonoscopy)
Assessment of Genetics
Genetic data investigated by another cohort study (IBD BioResource study) will be utilized in the analysis of this study.
Assessment of Quality of Life
Investigating QOL by questionnaires.
Assessment of Biological factors
Investigating colon biopsy samples (Colon biopsy samples are obtained when colonoscopy is performed for clinical reasons).
Locations (1)
Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London
London, United Kingdom