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

Queen's University2 个研究点分布在 1 个国家目标入组 200 人开始时间: 2017年8月10日最近更新: 2017年10月4日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Queen's University
入组人数: 200
试验地点: 2
主要终点: Bowel sensory threshold

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

IBS is a clinical entity characterized by abdominal pain and altered bowel movements. About 20% of the western population is affected by IBS. Abnormal perception of visceral stimuli plays a paramount role in the pathogenesis of IBS related abdominal pain. Moreover, sensitization (modulation of intracellular mechanisms leading to exaggerated action potential discharge in response to a given stimulus) of nociceptive dorsal root ganglia (DRG) neurons by tissue mediators is a fundamental mechanism underlying abnormal pain signaling. Clinical management of IBS has consisted primarily of symptomatic management of the altered bowel movement pattern. Although these can also afford improvement in abdominal pain, pharmacotherapy directly targeting bowel hypersensitivity are limited. Tri-cyclic antidepressants have been used in small doses in selected IBS patients who have not responded to first line therapy, but anti-cholinergic side effects have limited their use. The low FODMAP diet is well described therapeutic intervention which also targets bowel hypersensitivity, and about 70% of patients respond to this intervention. However, predictors of response to the various IBS therapies are lacking, and treatment decisions are often made on a "trial and error" fashion.

Assessment of bowel sensitivity has been reported using a barostat (an elastic balloon inflated manually by a syringe until rectal sensations are reported). Unfortunately, barostat device use has not been practical because considerable time is required to carry out the studies (up to 60 min). As such, barostat studies have been used mainly in research settings.

The rapid barostat bag (RBB) is a novel handheld barostat device. It is quick and simple to use, and its polyethylene bag provides superior volume measurements than the elastic balloons currently in use. This test could ultimately provide a bedside measure in the clinic of patients and identify those who are hypersensitive and thus more likely to respond to therapies targeting this sensory disorder. Data on validation of the RBB method against the standard barostat system has been published, using healthy volunteers. However, no studies evaluating the use of the RBB to assess bowel visceral sensitivity have been published to date.

Thus, there are 2 aims to this study:

Aim 1. To evaluate bowel sensitivity in IBS patients, compared with healthy controls.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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)

研究组 & 干预措施

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.