RecruitingNCT04995224

Mechanism of Chronic Pain in Patients With IBD

Psychophysiological and Biological Profiling of Chronic Pain in Patients With Inflammatory Bowel Disease


Sponsor

Queen Mary University of London

Enrollment

25,600 participants

Start Date

Jul 26, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Assessment of Biological factors, Assessment of Biological factors, and others for people with inflammatory bowel diseases. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAssessment of Psychophysiological factors

Investigating the presence of psychophysiological factors (depression, anxiety, catastrophizing) by questionnaires.

BIOLOGICALAssessment 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)

GENETICAssessment of Genetics

Genetic data investigated by another cohort study (IBD BioResource study) will be utilized in the analysis of this study.

BEHAVIORALAssessment of Quality of Life

Investigating QOL by questionnaires.

BIOLOGICALAssessment 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

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NCT04995224


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