Mechanism of Chronic Pain in Patients With IBD

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.

Conditions

• Inflammatory Bowel Diseases

Interventions

OTHER

Assessment of Psychophysiological factors

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

BIOLOGICAL

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)

GENETIC

Assessment of Genetics

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

BEHAVIORAL

Assessment of Quality of Life

Investigating QOL by questionnaires.

BIOLOGICAL

Assessment of Biological factors

Investigating colon biopsy samples (Colon biopsy samples are obtained when colonoscopy is performed for clinical reasons).

Sponsors & Collaborators

• University of Birmingham

  collaborator OTHER

• University of Cambridge

  collaborator OTHER

• Barking, Havering and Redbridge University Hospitals NHS Trust

  collaborator OTHER

• Barts & The London NHS Trust

  collaborator OTHER

• University College London Hospitals

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• King's College London

  collaborator OTHER

• Queen Mary University of London

  lead OTHER

Principal Investigators

• Qasim Aziz · Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-26

Primary Completion

2027-09-30

Completion

2027-09-30

Countries

• United Kingdom

Study Locations