Mechanism of Chronic Pain in Patients With IBD
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Other: Assessment of Psychophysiological factorsGenetic: Assessment of GeneticsBiological: Assessment of Biological factorsBehavioral: Assessment of Quality of Life
- Registration Number
- NCT04995224
- Lead Sponsor
- Queen Mary University of London
- Brief 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.
- Detailed Description
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 (UC and CD) over 18 months to identify risk factors related to the brain-gut axis for the development of chronic pain.
First assessment period: On the first day of the study, we will have a video chat with the participant using one of the telecommunications applications (e.g. skype, zoom, Microsoft team, etc.) and obtain an electric consent form using DocuSign (https://www.docusign.co.uk/). Then, participants will be trained on how to use online validated questionnaires to evaluate their disease activity, symptoms and psychological state, presence or absence of irritable bowel syndrome (IBS), or pain elsewhere. Then, they will be asked to download a mobile phone camera heart rate variability app and be trained to use it. They will also be trained to use the experience sampling method (ESM) to profile gut symptoms and lifestyle via a smartphone app at 10 random times in a day.
After training, participants will fill out baseline online questionnaires using REDCap. Participants will also start answering questionnaires by ESM for 7 days and recording their heart rate (5 minutes) using the app once a day in the morning for 7 days.
2nd-4th assessment periods: Further assessment periods will be scheduled every 6 months. One-two days before each study period begins, we will remind the participants by email or phone call. On day 1, participants fill out the same online questionnaires (except personality, which is a stable trait) followed by 7 days ESM profiling as during their first assessment period. They will also be asked to record heart rate (5 minutes) once a day in the morning for 7days. Each patient will be followed at least 18 months until the 4th assessment period ends.
If patients agree, we will add online questionnaires to patients beyond the life of the grant (at 24 months and 36 months) when they are followed by the IBD BioResource inception study. (ESM and sample collection are not performed after 18 months follow)
This is a collaborative study with the IBD BioResource Inception study. The participants in our study will be asked to participate in the IBD BioResource Inception study as well. Biological data obtained by the BioResource Inception study, which will be used for the analysis.
Study 1B: This is also a collaborative study with the Inception study. Data for 600 patients will still need to be collected by the Inception study when our study starts. We will apply for our detailed questionnaires for 7 days (as per study 1A) to be administered to all the new patients that are included in the Inception study on a voluntary basis. This will allow us to capture data on almost 600 patients (150 of these will be from study 1A).
Using both our 150 studied patients from study1A and 450 patients in the Inception cohort (study 1B), we will then use cutting edge techniques in machine learning to ascertain if artificial intelligence (AI) can predict individuals who will develop chronic abdominal pain.
Study 2 and 3: Study 2 and 3 are a questionnaire-based cross-sectional study in patients with IBD (both CD and UC patients). The participants for study 2 are patients who are registered in IBD BOOST study and those for study 3 are patients who are registered in IBD BioResource (but not in IBD Boost study).
The aims are to determine the prevalence of chronic pain in Crohn's and UC patients, the prevalence of comorbid pain and IBS, lifestyle factors, and quality of life. IBD BOOST questionnaire is due to be administered to 10,000 patients. We will invite these patients to complete additional questionnaires not covered by IBD BOOST. We also approach 15,000 patients from IBD BioResourse who are not included in the IBD Boost study and administer questionnaires to them. We will be able to identify risk factors and aid a predictive model from static time point data if a number of those individuals have pain and a number do not. Further, in study 2 and 3, we will be able to determine whether the risk factors identified in study 1A and 1B accurately identify patients with and without chronic pain.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25600
Not provided
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study 1B Assessment of Genetics Prospective cohort study with 450 newly diagnosed patients with IBD Study 1A Assessment of Quality of Life Prospective cohort study with 150 newly diagnosed patients with inflammatory bowel disease Study 1A Assessment of Biological factors Prospective cohort study with 150 newly diagnosed patients with inflammatory bowel disease Study 3 Assessment of Psychophysiological factors Cross-sectional study with 15,000 patients in IBD BioResource Study 1A Assessment of Psychophysiological factors Prospective cohort study with 150 newly diagnosed patients with inflammatory bowel disease Study 1A Assessment of Genetics Prospective cohort study with 150 newly diagnosed patients with inflammatory bowel disease Study 1B Assessment of Quality of Life Prospective cohort study with 450 newly diagnosed patients with IBD Study 1B Assessment of Psychophysiological factors Prospective cohort study with 450 newly diagnosed patients with IBD Study 1B Assessment of Biological factors Prospective cohort study with 450 newly diagnosed patients with IBD Study 2 Assessment of Psychophysiological factors Cross-sectional study with 10,000 patients in IBD Boost study Study 2 Assessment of Genetics Cross-sectional study with 10,000 patients in IBD Boost study Study 3 Assessment of Genetics Cross-sectional study with 15,000 patients in IBD BioResource Study 3 Assessment of Quality of Life Cross-sectional study with 15,000 patients in IBD BioResource Study 2 Assessment of Quality of Life Cross-sectional study with 10,000 patients in IBD Boost study
- Primary Outcome Measures
Name Time Method Identification of psychophysiological and biological risk factors for development of chronic abdominal pain 3 years 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
Build predictive models for chronic pain using artificial intelligence and machine learning 3 years 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
- Secondary Outcome Measures
Name Time Method Environmental sensitivity 3 years To study environmental sensitivity in patients with IBD
Prevalence of IBS in IBD remission 3 years To identify the prevalence of IBS in patients with IBD in remission
Chronic abdominal pain prevalence 3 years To determine the prevalence of chronic abdominal pain
Co-morbid pain in IBD remission 3 years To determine the prevalence of co-morbid pain in patients with IBD in remission
Lifestyle factors and quality of life 3 years To study fatigue, lifestyle factors (e.g. sleep quality and dietary habits) and quality of life
Trial Locations
- Locations (1)
Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London
🇬🇧London, United Kingdom