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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    Page 1 of 1 (3 locations)

    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