Evaluation of Bowel Sensitivity Threshold in IBS Patients Versus in Healthy Controls Using the Novel Rapid Barostat Bag

Summary

BACKGROUND \& AIMS: Bowel hypersensitivity (lower threshold for discomfort in response to distention of a balloon in the rectum compared to healthy controls) is a key documented feature in Irritable Bowel Syndrome (IBS) mechanistic studies. The use of the barostat catheter to assess bowel hypersensitivity has been well documented in research settings, but it's use is time consuming which makes it unpractical for routine clinical practice (test time up to 60 minutes). The Rapid Barostat Bag is a novel device used to obtain a rapid and simple assessment of the rectal function, which has received approval for use by Health Canada. Although its safety and use has been validated in healthy controls, RBB use has never been reported in a cohort of IBS patients. The aim of this study is to 1) evaluate bowel sensitivity in IBS patients, compared with healthy controls and 2) determine whether the sensory threshold predicts response to standard of care interventions such as diet or medications.

METHODS: This is a prospective controlled study. All participants will undergo RBB testing and will answer a questionnaire related to bowel symptoms (IBS-SSS - IBS Severity Scoring System) and a questionnaire related to anxiety/depression (HADS - Hospital and Anxiety and Depression Scale).

HYPOTHESIS: The investigators hypothesize that IBS patients will display lower bowel sensitivity thresholds than healthy controls, using the RBB device. Furthermore, we predict that those with a low sensory threshold (i.e. visceral hypersensitivity) are most likely to respond to interventions that decrease bowel distention (e.g. low FODMAP diet) or the medication linaclotide that is reported to decrease pain signaling.

Conditions

• Irritable Bowel Syndrome
• Visceral Hypersensitivity

Interventions

DEVICE

Rapid Barostat Bag

Both healthy controls (n= 100) and IBS patients (n=100) will undergo anorectal studies using a Rapid barostat bag catheter.

OTHER

IBS severity scoring system questionnaire (IBS-SSS)

We will correlate the changes to IBS symptoms using the IBS severity scoring system questionnaire (IBS-SSS). The questionnaire will be administered twice for IBS patients who have consented to return for a second study visit, at each of the two RBB studies.

OTHER

HAD scale questionnaire

It is a validated anxiety and depression questionnaire

Sponsors & Collaborators

• Queen's University

  lead OTHER

Principal Investigators

• Stephen Vanner, MD · Queen's University

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-10

Primary Completion

2019-07-15

Completion

2019-07-15

Countries

• Canada

Study Locations