Understanding Abdominal Pain in IBD and IBS

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04020835
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Guy's and St Thomas' NHS Foundation Trust
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Abdominal Pain, Inflammatory Bowel Diseases, Irritable Bowel Syndrome
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Barts Health NHS Trust, London, United Kingdom

Status

Not yet recruiting

Address

Barts Health NHS Trust

London, ,

Site Contact

King's College Hospital NHS Foundation Trust

danielle.huisman@kcl.ac.uk

+442071880188

London, United Kingdom

Status

Recruiting

Address

Guy's and St Thomas' NHS Foundation Trust

London, ,

Site Contact

Consultant Gastroenterologist

danielle.huisman@kcl.ac.uk

+442071880188

London, United Kingdom

Status

Not yet recruiting

Address

King's College Hospital NHS Foundation Trust

London, ,

Site Contact

Consultant Gastroenterologist

danielle.huisman@kcl.ac.uk

+442071880188

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