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

NCT03224494 | Unknown

• 1 other identifier: 6021016
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Bowel sensory threshold

  Sensory thresholds are obtained via rapid barostat bag measurements, and are expressed in millilitres.

  A second visit to record sensory threshold a second time may be obtained up to 52 weeks after the first visit.

Secondary Outcomes (2)

• IBS-SSS Questionnaire

  At first visit, and during a second visit. A second visit may be obtained up to 52 weeks after the first visit.

• HADS scale questionnaire

  At first visit, and during a second visit. A second visit may be obtained up to 52 weeks after the first visit.

Study Arms (2)

IBS Patients

OTHER

Patients 18 years or older with a diagnosis of irritable bowel symptom, as per Rome IV criteria. The diagnosis is established by the patient's gastroenterologist. Please see inclusion and exclusion section for more details. They will undergo Rapid Barostat Bag testing, and they will answer the IBS severity scoring system questionnaire (IBS-SSS) and HAD scale questionnaire.

Device: Rapid Barostat Bag; Other: IBS severity scoring system questionnaire (IBS-SSS); Other: HAD scale questionnaire

Healthy Controls

OTHER

Patients 18 years of age without IBS or other colo-rectal symptoms or pathology seen for other issues in the general GI clinic. They will undergo Rapid Barostat Bag testing, and they will answer the IBS severity scoring system questionnaire (IBS-SSS) and HAD scale questionnaire.

Device: Rapid Barostat Bag; Other: IBS severity scoring system questionnaire (IBS-SSS); Other: HAD scale questionnaire

Interventions

Rapid Barostat Bag DEVICE

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

Healthy Controls; IBS Patients

IBS severity scoring system questionnaire (IBS-SSS) OTHER

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.

Healthy Controls; IBS Patients

HAD scale questionnaire OTHER

It is a validated anxiety and depression questionnaire

Healthy Controls; IBS Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with IBS by their treating gastroenterologist, according to the Rome IV criteria. According to Rome IV criteria, IBS is defined as:
• recurrent abdominal pain, on average, at least one day per week in the last three months, associated with 2 or more of the following:
• pain is related to defecation
• associated with a change in stool frequency
• associated with a change in stool form.
• Irritable Bowel syndrome patients will be recruited from the GI motility clinic and general GI clinic at Hotel Dieu Hospital.
• Healthy controls will be recruited from the GI clinics. These are patients coming for evaluation for non-colonic symptoms such as colon screening, gastroesophageal reflux disease, or liver disease.

You may not qualify if:

• patients under the age of 18;
• a recent change in IBS treatment regimen or patients taking analgesics, which may affect bowel sensitivity (this includes the FODMAP diet)
• pregnant patients, as there may be a small risk of inducing labor with the barostat probe
• patients who have had previous colorectal surgery as it may bowel sensitivity
• healthy controls who are experiencing bowel symptoms
• known significant anorectal pathology (eg. fistulae, abscess, stricture, etc)

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston Health Sciences Centre - HDH site

Kingston, Ontario, K7L5G2, Canada

RECRUITING

Related Publications (2)

• Sauter M, Heinrich H, Fox M, Misselwitz B, Halama M, Schwizer W, Fried M, Fruehauf H. Toward more accurate measurements of anorectal motor and sensory function in routine clinical practice: validation of high-resolution anorectal manometry and Rapid Barostat Bag measurements of rectal function. Neurogastroenterol Motil. 2014 May;26(5):685-95. doi: 10.1111/nmo.12317. Epub 2014 Feb 12.

  PMID: 24517865 BACKGROUND

• Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.

  PMID: 24076059 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Stephen Vanner, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Vanner, MD

CONTACT

613-544-3400; vanners@hdh.kari.net

Celine Morissette

CONTACT

613-544-3400; morissc@hdh.kari.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 21, 2017
• Study Start: August 10, 2017
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: October 4, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)