NCT05185609

Assessment of Anorectal Function in Patients With Inflammatory Bowel Disease

Recruiting now Last updated 3 February 2022

What this trial tests

trial testing Exposure 1: Visceral hypersensitivity or phenotype suggestive of IBS in Inflammatory Bowel Diseases in 70 participants. Currently enrolling.

Timeline

1 September 2021

Primary endpoint
30 December 2027

30 December 2027

Quick facts

Lead sponsor	Region Örebro County
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	70
Start date	1 September 2021
Primary completion	30 December 2027
Estimated completion	30 December 2027
Sites	1 location across Sweden

Drugs / interventions tested

• Exposure 1: Visceral hypersensitivity or phenotype suggestive of IBS
• Exposure 2: Changes in anorectal motor function or compliance.

Conditions studied

• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

Region Örebro County — full company profile →

Who can join

Adults 18 to 65, any sex, with Inflammatory Bowel Diseases or Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Active inflammatory bowel disease (IBD) causes disabling symptoms such as diarrhea, involuntary loss of bowel control, abdominal pain and urges to pass stool. However, even patients with inactive IBD frequently experience such symptoms. The cause is not well understood and the functionality of the bowel in IBD patients is underexplored.

Earlier studies show a wide range of results, but most find that patients with IBD in remission are up to four times as likely to report gastrointestinal symptoms when compared to healthy controls.

Chronic inflammation may cause changes of the bowel wall, like increased collagen deposits (fibrosis) and thus cause symptoms, but the absence of active inflammation in combination with presence of symptoms may also be regarded as resembling the clinical condition of irritable bowel syndrome (IBS).

IBS is characterized by abdominal pain and changes in stool frequency and consistence and is often associated with disorders like depression and anxiety. Up to a third of IBD patients without signs of disease activity meet the criteria for IBS (irritable bowel syndrome. It can be speculated that an IBD diagnosis is a distressing event that can induce mood disorders, and an IBS-like condition.

Characterization of IBS patients relies on the Rome IV symptom criteria, symptom severity scales and measurements of rectal sensibility and rectal compliance using a barostat procedure.

Motor function assessment relies on anorectal manometry which detects abnormalities of muscle function and coordination. Recently, a standardized high-resolution anorectal manometry protocol (HRAM) was published which also evaluates sensitivity and compliance. The level of agreement between the barostat method and the HRAM testing procedure regarding sensibility and rectal compliance is largely unknown.

Recent studies have associated gut microorganisms, genetic factors, and proteins with various aspects of IBD. There is evidence that these potential markers may reflect non-inflammatory processes such as fibrosis.

The aim of this study is to explore the anorectal function in symptomatic patients with inactive IBD compared to healthy volunteers and asymptomatic patients, evaluate symptom severity and psychological parameters and perform molecular characterization.

The level of agreement of rectal sensitivity and compliance measurements with the barostat method and HRAM protocol will also be evaluated.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.