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
This trial does not accept healthy volunteersQualifiers
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 population
The study population is males and females over the age of 18 who have been diagnosed with ulcerative colitis or Crohn's disease within the past 6 months before enrolment.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Assessment of Psychophysiological factors
Other interventionInvestigating the presence of psychophysiological factors (depression, anxiety, catastrophizing) by questionnaires.
Assessment of Biological factors
Biological/VaccineInvestigating 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)
Assessment of Genetics
GeneticGenetic data investigated by another cohort study (IBD BioResource study) will be utilized in the analysis of this study.
Assessment of Quality of Life
BehavioralInvestigating QOL by questionnaires.
Assessment of Biological factors
Biological/VaccineInvestigating colon biopsy samples (Colon biopsy samples are obtained when colonoscopy is performed for clinical reasons).
Treatment groups
25,600 Participants
are divided into 4 treatment groupsGroup A: Study 1A4 interventions
Group B: Study 1B4 interventions
Group C: Study 23 interventions
Group D: Study 33 interventions
Trial outcomes
Primary outcomes
1
Identification of psychophysiological and biological risk factors for development of chronic abdominal pain
To identify psychophysiological and biological risk factors for the development of chronic abdominal pain in patients with newly diagnosed inflammatory bowel disease (ulcerative colitis and Crohn's disease) in a prospective longitudinal cohort study design
Time frame
3 years2
Build predictive models for chronic pain using artificial intelligence and machine learning
To use artificial intelligence (AI) and machine learning (ML) to build predictive models that use longitudinal data to identify patients who will develop chronic pain
Time frame
3 yearsSecondary outcomes
1
Chronic abdominal pain prevalence
To determine the prevalence of chronic abdominal pain
Time frame
3 years2
Co-morbid pain in IBD remission
To determine the prevalence of co-morbid pain in patients with IBD in remission
Time frame
3 years3
Lifestyle factors and quality of life
To study fatigue, lifestyle factors (e.g. sleep quality and dietary habits) and quality of life
Time frame
3 years4
Environmental sensitivity
To study environmental sensitivity in patients with IBD
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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