Understanding Chronic Pain in Patients with Inflammatory Bowel Disease
Psychophysiological and Biological Profiling of Chronic Pain in Patients With Inflammatory Bowel Disease
This study is trying to find out what causes chronic abdominal pain in people who have just been diagnosed with inflammatory bowel disease, like ulcerative colitis and Crohn's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04995224 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify psychophysiological and biological risk factors contributing to chronic abdominal pain in patients newly diagnosed with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. Over 18 months, 150 participants will undergo a longitudinal assessment involving online questionnaires, stool and blood sample collection, and heart rate monitoring. The study will utilize a combination of telecommunication for consent and training, as well as mobile applications for real-time symptom tracking. The findings may help clarify the mechanisms behind chronic pain in IBD patients, even during remission.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been diagnosed with ulcerative colitis or Crohn's disease within the last 6 months.
Not a fit: Patients with severe extensive colitis at risk of colectomy or those with other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of chronic pain in IBD patients, enhancing their quality of life.
How similar studies have performed: While the specific mechanisms of chronic pain in IBD are not extensively studied, similar approaches in understanding pain mechanisms in other chronic conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : * 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. Exclusion Criteria: * Patients who have severe extensive colitis and are at imminent risk of colectomy. * Patients who already have the presence of a stoma or history of a fistula or stricture due to another diagnosis. * Patients who are pregnant, lactating or thinking of becoming pregnant during the study period * Patients who have unstable acute illness or exacerbation of an unstable chronic illness or chronic disease (other than IBD) that may affect assessments for this study as determined by previous physical examination, medical history, vital signs, ECG, and laboratory (serum biochemistry, hematology, urinalysis) assessments. * Patients with a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection that are not in remission and are on medication that can affect gastrointestinal function. * Patients who have known or suspected to have a severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure (CHF) and chronic arrhythmia such as atrial fibrillation * Patients who have known or suspected cerebrovascular disease (e.g. prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery) * Patients who have a known history or suspected history of substance abuse or addiction (within the last five years).
Where this trial is running
London
- Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Qasim Aziz — Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London
- Study coordinator: Iman Khwaja
- Email: i.khwaja@qmul.ac.uk
- Phone: 02078822655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.