An observational study in Irritable Bowel Syndrome, sponsored by Northwell Health. Terminated at 1 site in United States. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-22.
Sponsored by Northwell Health · Observational
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 2 is below the median of 150 across 178 observational studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.
Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with who are undergoing routine screening colonoscopies.
Exclusion Criteria:
GI symptoms, conditions and disorders: In addition exclusion criteria will include a history of ileocecal resection or disease affecting the colon and/or small bowel including crohn's disease, ulcerative colitis or diseases causing diarrhea.
Normal volunteers without Irritable bowel syndrome who are undergoing screening colonoscopy.
Patients with Irritable bowel syndrome are undergoing colonoscopy as standard of care.
Pressure generated in ICV during Cecal distention
Time frame: 10-15 minutes
Plan to share: No
This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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