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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Behavioral, Other, Genetic
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Males or females who are over 18 years old.

• Patients who are diagnosed with UC or CD within 6 months before the enrolment.

• Patients who have access to the internet and have the IT skills to perform basic tasks e.g. operate emails and fill out questionnaires.

• Patients who are willing and able to participate in the study for the required duration, can understand and are willing to sign the consent forms and agree to undergo all protocol-related tests and procedures.

Locations
Other Locations
United Kingdom
Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London
RECRUITING
London
Contact Information
Primary
Iman Khwaja
i.khwaja@qmul.ac.uk
02078822655
Backup
Kazuya Takahashi
kazuya.takahashi@qmul.ac.uk
02078822655
Time Frame
Start Date: 2021-07-26
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 25600
Treatments
Study 1A
Prospective cohort study with 150 newly diagnosed patients with inflammatory bowel disease
Study 1B
Prospective cohort study with 450 newly diagnosed patients with IBD
Study 2
Cross-sectional study with 10,000 patients in IBD Boost study
Study 3
Cross-sectional study with 15,000 patients in IBD BioResource
Sponsors
Collaborators: University of Cambridge, Royal Free Hospital NHS Foundation Trust, Barts & The London NHS Trust, University of Birmingham, University College London Hospitals, King's College London, Barking, Havering and Redbridge University Hospitals NHS Trust
Leads: Queen Mary University of London

This content was sourced from clinicaltrials.gov