Mechanism of Chronic Pain in Patients With IBD
Psychophysiological and Biological Profiling of Chronic Pain in Patients With Inflammatory Bowel Disease
Queen Mary University of London
25,600 participants
Jul 26, 2021
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
Inclusion Criteria4
- 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 Criteria8
- 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).
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Interventions
Investigating the presence of psychophysiological factors (depression, anxiety, catastrophizing) by questionnaires.
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 data investigated by another cohort study (IBD BioResource study) will be utilized in the analysis of this study.
Investigating QOL by questionnaires.
Investigating colon biopsy samples (Colon biopsy samples are obtained when colonoscopy is performed for clinical reasons).
Locations(1)
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NCT04995224