Status:
UNKNOWN
Understanding Abdominal Pain in IBD and IBS
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
Conditions:
Abdominal Pain
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Brief Summary
Abdominal pain is a central symptom of Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS). IBD is an autoimmune disease characterized by inflammation of the gastrointestinal tract. IB...
Detailed Description
It remains unclear why a large proportion of people with inflammatory bowel disease (IBD) report ongoing abdominal pain during remission or why people with irritable bowel syndrome (IBS) develop abdom...
Eligibility Criteria
Inclusion
- General inclusion criteria:
- Aged 18 and over
- Sufficient command of written and spoken English
- IBD in remission inclusion criteria:
- Proof of diagnosis of IBD (Crohn's disease or ulcerative colitis) for more than 6 months - - Clear indicators of remission: on faecal calprotectin (≤200 µg/g) or measurements of C-reactive protein (CRP; ≤10 mg/dl) within the last 3 months or as part of recruitment
- No previous episodes of acute or sub-acute obstruction
- IBS inclusion criteria:
- Current diagnosis of IBS measured with Rome IV criteria
- No serious other bowel diseases
- Exclusion criteria:
- Major abdominal surgery in the last 6 months, or 3 or more previous major abdominal surgeries
- Pregnancy or childbirth in the last 6 months
- Any other diagnosed medical condition that may explain abdominal pain, including but not limited to known gynaecological conditions such as endometriosis and known post-surgical adhesions
- Any diagnosed co-morbid medical conditions associated with known neuropathy, such as diabetic neuropathy, renal neuropathy, multiple sclerosis
- Use of opioids in the last week
- Use of anti-depressants used as pain medication in the last month
Exclusion
Key Trial Info
Start Date :
May 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04020835
Start Date
May 20 2019
End Date
March 31 2020
Last Update
July 18 2019
Active Locations (3)
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1
Barts Health NHS Trust
London, United Kingdom
2
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
3
King's College Hospital NHS Foundation Trust
London, United Kingdom