Understanding Chronic Pain in Patients with Inflammatory Bowel Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify psychophysiological and biological risk factors contributing to chronic abdominal pain in patients newly diagnosed with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. Over 18 months, 150 participants will undergo a longitudinal assessment involving online questionnaires, stool and blood sample collection, and heart rate monitoring. The study will utilize a combination of telecommunication for consent and training, as well as mobile applications for real-time symptom tracking. The findings may help clarify the mechanisms behind chronic pain in IBD patients, even during remission.

Why it matters

Who can join: the full rules

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).

Where it's running

• Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Qasim Aziz — Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London
• Study coordinator: Iman Khwaja
• Email: i.khwaja@qmul.ac.uk
• Phone: 02078822655

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-Term Guselkumab Use in Adults with Inflammatory Bowel Disease

  This study looks at how long adults with Crohn's disease or ulcerative colitis stay on guselkumab in real-world care.

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• Intestinal ultrasound-guided management for inflammatory bowel disease

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• Resting energy use in kids with inflammatory bowel disease

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  Recruiting Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Alessandria, Piedmont · NCT07670975

• Active video education by disease subtype to improve bowel prep before colonoscopy

  We’re testing whether adding subtype-specific video education to standard prep improves bowel cleanliness in adults with IBD undergoing colonoscopy.

  Recruiting at 12 sites Xijing Hospital of Digestive Diseases · Beijing, BeijingBeijing and 11 other locations · NCT07582731

• Intestinal ultrasound to predict relapse in Crohn's disease patients in deep remission.

  This project will try to see if a noninvasive transabdominal ultrasound can predict relapses in adults with Crohn's disease who are currently in deep remission.

  Recruiting Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT07539727

• Ath-063: Testing a new treatment for moderately to severely active ulcerative colitis in patients who have tried other biologics

  This study tests ATH-063 to see if it helps people with moderate to severe ulcerative colitis who did not respond to or relapsed after prior biologic therapy.

  Recruiting at 4 sites Phase 2 Athos Therapeutics Inc · Miami, Florida and 3 other locations · NCT07513181

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.