Psychophysiological and Biological Profiling of Chronic Pain in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25,600
- 试验地点
- 2
- 主要终点
- Identification of psychophysiological and biological risk factors for development of chronic abdominal pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Study 3
Cross-sectional study with 15,000 patients in IBD BioResource
干预措施: Assessment of Psychophysiological factors (Other)
Study 2
Cross-sectional study with 10,000 patients in IBD Boost study
干预措施: Assessment of Quality of Life (Behavioral)
Study 3
Cross-sectional study with 15,000 patients in IBD BioResource
干预措施: Assessment of Genetics (Genetic)
Study 3
Cross-sectional study with 15,000 patients in IBD BioResource
干预措施: Assessment of Quality of Life (Behavioral)
Study 1A
Prospective cohort study with 150 newly diagnosed patients with inflammatory bowel disease
干预措施: Assessment of Psychophysiological factors (Other)
Study 1A
Prospective cohort study with 150 newly diagnosed patients with inflammatory bowel disease
干预措施: Assessment of Biological factors (Biological)
Study 1A
Prospective cohort study with 150 newly diagnosed patients with inflammatory bowel disease
干预措施: Assessment of Genetics (Genetic)
Study 1A
Prospective cohort study with 150 newly diagnosed patients with inflammatory bowel disease
干预措施: Assessment of Quality of Life (Behavioral)
Study 1B
Prospective cohort study with 450 newly diagnosed patients with IBD
干预措施: Assessment of Psychophysiological factors (Other)
Study 1B
Prospective cohort study with 450 newly diagnosed patients with IBD
干预措施: Assessment of Genetics (Genetic)
Study 1B
Prospective cohort study with 450 newly diagnosed patients with IBD
干预措施: Assessment of Quality of Life (Behavioral)
Study 1B
Prospective cohort study with 450 newly diagnosed patients with IBD
干预措施: Assessment of Biological factors (Biological)
Study 2
Cross-sectional study with 10,000 patients in IBD Boost study
干预措施: Assessment of Psychophysiological factors (Other)
Study 2
Cross-sectional study with 10,000 patients in IBD Boost study
干预措施: Assessment of Genetics (Genetic)
结局指标
主要结局
Identification of psychophysiological and biological risk factors for development of chronic abdominal pain
时间窗: 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
时间窗: 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
次要结局
- Environmental sensitivity(3 years)
- Prevalence of IBS in IBD remission(3 years)
- Chronic abdominal pain prevalence(3 years)
- Co-morbid pain in IBD remission(3 years)
- Lifestyle factors and quality of life(3 years)