Mechanism of Chronic Pain in Patients With IBD
ConditionInflammatory Bowel Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQueen Mary University of London
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Assessment of Psychophysiological factors
- Assessment of Biological factors
- Assessment of Genetics
- Assessment of Quality of Life
- Assessment of Biological factors
Treatment groups
25,600 Participants
are divided into 4 treatment groupsSponsors and collaborators
Queen Mary University of London
Lead sponsor
University of Birmingham
Collaborator
University of Cambridge
Collaborator
Barking, Havering and Redbridge University Hospitals NHS Trust
Collaborator
Barts & The London NHS Trust
Collaborator
University College London Hospitals
Collaborator
Royal Free Hospital NHS Foundation Trust
Collaborator
King's College London
Collaborator
Source ClinicalTrials.gov