Mechanism of Chronic Pain in Patients With IBD

Launched by QUEEN MARY UNIVERSITY OF LONDON · Jul 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying why some patients with inflammatory bowel disease (IBD) continue to experience chronic abdominal pain even when their condition is under control. The research aims to find out what psychological and biological factors might contribute to this ongoing pain in patients who have recently been diagnosed with IBD, which includes conditions like ulcerative colitis and Crohn's disease.

To participate in this study, you need to be over 18 years old and diagnosed with IBD within the last six months. Participants will take part in various assessments over an 18-month period, including filling out online questionnaires, providing stool and blood samples, and recording heart rate data. You will be asked to complete these assessments from home, and your involvement is voluntary. This study is important because it seeks to improve our understanding of chronic pain in IBD, ultimately helping to enhance treatment and support for patients like you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria :
• • 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 Criteria:
• • 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).