Actively Recruiting
Mechanism of Chronic Pain in Patients With IBD
Led by Queen Mary University of London · Updated on 2025-07-24
25600
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
Sponsors
Q
Queen Mary University of London
Lead Sponsor
U
University of Birmingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Mechanism of Chronic Pain in Patients With IBD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with ulcerative colitis or Crohn's disease within 6 months before enrollment
- Have internet access and the ability to use basic online tools such as email and questionnaires
- Willing and able to participate for the full study duration, understand and sign consent forms, and complete all study procedures
You will not qualify if you...
- Severe extensive colitis with imminent risk of colectomy
- Presence of a stoma or history of fistula or stricture due to another diagnosis
- Pregnant, lactating, or planning pregnancy during the study
- Unstable acute illness or worsening chronic illness other than IBD affecting study assessments
- Active hepatitis B, hepatitis C, or HIV infection on medication affecting gastrointestinal function
- Known or suspected severe cardiac disease (e.g., coronary artery disease, heart failure, arrhythmia)
- Known or suspected cerebrovascular disease (e.g., prior stroke, carotid artery disease, vascular surgery)
- History or suspicion of substance abuse or addiction within the last five years
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Trial Site Locations
Total: 1 location
1
Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London
London, United Kingdom, E1 2AJ
Actively Recruiting
Research Team
I
Iman Khwaja
CONTACT
K
Kazuya Takahashi
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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