IBD (general)Recruiting
Mechanism of Chronic Pain in Patients With IBD
Observational · No treatment assigned · 1 site · Queen Mary University of London
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 1 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 25600 participants are expected to take part.
- Start date: 2021-07-26.
- Main results expected around 2027-09-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United Kingdom.
Main thing being measured
- Identification of psychophysiological and biological risk factors for development of chronic abdominal pain (3 years)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | Queen Mary University of London |
| Collaborators | University of Birmingham; University of Cambridge; Barking, Havering and Redbridge University Hospitals NHS Trust; Barts & The London NHS Trust; University College London Hospitals; Royal Free Hospital NHS Foundation Trust; King's College London |
| Enrollment | 25600 (estimated) |
| Start date | 2021-07-26 |
| Primary completion (est.) | 2027-09-30 |
| First posted | 2021-08-06 |
| Last updated | 2026-05-22 |
| Official title | Psychophysiological and Biological Profiling of Chronic Pain in Patients With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT04995224 |
Interventions
- Assessment of Psychophysiological factors (Other)
Investigating the presence of psychophysiological factors (depression, anxiety, catastrophizing) by questionnaires. - Assessment of Biological factors (Biological)
Investigating 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 (Genetic)
Genetic data investigated by another cohort study (IBD BioResource study) will be utilized in the analysis of this study. - Assessment of Quality of Life (Behavioral)
Investigating QOL by questionnaires. - Assessment of Biological factors (Biological)
Investigating colon biopsy samples (Colon biopsy samples are obtained when colonoscopy is performed for clinical reasons).
Full eligibility criteria (from the record)
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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London | London | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.