Ileocecal Sphincter Reflex by Cecal Distension During Colonoscopy
|ClinicalTrials.gov Identifier: NCT01413945|
Recruitment Status : Suspended (Waiting to complete some logistics)
First Posted : August 10, 2011
Last Update Posted : February 6, 2018
The aim of the current study is to test the hypothesis that patients with IBS may have a defective ICV pressures and may have small bowel bacterial overgrowth. The goal of the current study is to identify the role and competence of ileocecal valve (ICV) in patients with irritable bowel syndrome.
The primary objective is to measure the pressure of the ileocecal valve in patients with and without irritable bowel syndrome (IBS). The Ileocecal valve reflux pressures during air insufflation of cecum will be used.
|Condition or disease|
|Irritable Bowel Syndrome|
This is an outpatient study. There will be no requirement to stay overnight in the hospital. The research will be conducted in the gastroenterology section of the department of Medicine in North shore university hospital and in North shore long island Jewish medical center. Both these hospitals are tertiary care centers with adequate facilities for the safe and appropriate conduct of this research. Participants must meet all eligibility criteria and sign the consent form before enrolling in the study. This is a cohort study with 2 groups (patients with IBS and participants without IBS). Patients will be enrolled into one of these two categories based on their medical history, signs and symptoms and questionnaire. There are no controlled compounds used in this study. There is no treatment involved in this study. There are 2 study related visits per subject.
Based on questionnaire we plan to recruit 25 participants who meet the criteria of IBS and 25 participants who do not meet the criteria of IBS (Total of 50 participants in the study). Patients with IBS are those who meet the criteria of IBS based on their symptoms and the responses to a validated ROME III - questionnaire. All other participants who do not meet the criteria for IBS are classified as non-IBS participants. All the participants should be having a clinically indicated colonoscopy.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Evaluation of the Ileocecal Valve in Patients With and Without Irritable Bowel Syndrome.(IBS)|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Normal volunteers without Irritable bowel syndrome who are undergoing screening colonoscopy.
Irritable bowel syndrome
Patients with Irritable bowel syndrome are undergoing colonoscopy as standard of care.
- Pressure generated in ICV during Cecal distention [ Time Frame: 10-15 minutes ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413945
|United States, New York|
|LIJ Medical Center- NSLIJ Health System|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator:||Larry S Miller, MD||Northwell Health|