Understanding Abdominal Pain in IBD and IBS

NCT ID: NCT04020835

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-20

Study Completion Date

2020-03-31

Brief Summary

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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. IBS does not have clear biomarkers and is diagnosed based on symptom reports. The aim of this study is to explore biopsychosocial factors which may perpetuate and/or increase the severity of pain in these conditions. The main focus will be on the role of top-down brain processes in the experience of abdominal pain.

Detailed Description

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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 abdominal pain. One theory is that people with chronic pain have somehow grown more sensitive.

It is assumed that such heightened sensitivity depends both on bottom-up processing and top-down processing. Bottom-up processing refers to information that is relayed to the brain along so-called afferent fibres. Top-down processing refers to feedback provided by the brain to lower areas along efferent fibres.

The investigators will (1) measure the capacity of people to inhibit pain through top-down processing, (2) test if the human pain experience is enhanced due to sustained activation of certain afferents, and (3) assess to what extent people are impacted by psychosocial inhibition and activation factors. Results of people with IBS in remission will be compared with the results of two groups of people with IBD (those with pain and those without) and the investigators will explore if their measurements differentiate between groups.

It is hypothesized that (1) IBS patients and IBD patients with abdominal pain will be less able to inhibit their pain compared to IBD patients without abdominal pain (2) IBS patients and IBD patients with abdominal pain will score higher on psychosocial inhibition factors and lower on psychosocial activation factors when compared to IBD patients without abdominal pain. (3) In the total cohort, laboratory measures of pain inhibition will correlate with self-reported psychosocial inhibition and activation factors. (4) IBS patients and IBD patients with abdominal pain will show more temporal summation compared to IBD patients without abdominal pain.

Conditions

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Abdominal Pain Inflammatory Bowel Diseases Irritable Bowel Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Aged 18 and over
* Sufficient command of written and spoken English


* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barts Health NHS Trust

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

King's College Hospital NHS Foundation Trust

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United Kingdom

Central Contacts

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Danielle Huisman

Role: CONTACT

+442071880188

Reza Razavi

Role: CONTACT

+442078486390

Facility Contacts

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King's College Hospital NHS Foundation Trust

Role: primary

Consultant Gastroenterologist

Role: primary

Consultant Gastroenterologist

Role: primary

Other Identifiers

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253660

Identifier Type: -

Identifier Source: org_study_id

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