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Ileocecal Sphincter Reflex by Cecal Distension During Colonoscopy

This study is currently recruiting participants.
Verified December 2016 by Larry Miller, Northwell Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT01413945
First Posted: August 10, 2011
Last Update Posted: December 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Larry Miller, Northwell Health
  Purpose

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
Irritable Bowel Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Ileocecal Valve in Patients With and Without Irritable Bowel Syndrome.(IBS)

Further study details as provided by Larry Miller, Northwell Health:

Primary Outcome Measures:
  • Pressure generated in ICV during Cecal distention [ Time Frame: 10-15 minutes ]

Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal volunteers
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.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with who are undergoing routine screening colonoscopies.
Criteria

Inclusion Criteria:

  • Patients with a history of small bowel bacterial overgrowth or irritable bowel syndrome and who are undergoing routine colonoscopies or subjects who are undergoing routine colonoscopy and test positive for small bowel bacterial overgrowth will be candidates. If the patient has prior lactulose breath test done for clinical purposes then repeat lactulose breath test will not be required. If no prior lactulose breath test has been performed then it will be done as part of this research study. In addition patients who test negative for SBBO will be candidates for the control population.

Exclusion Criteria:

  • Medications-Subjects on any medication that could affect the ileocecal valve high-pressure zone will be excluded; this includes use of prokinetic agents, current use of any antibiotics and anticholinergics. Patients will be excluded if the lactulose breath test is done on antibiotics or during the colonoscopy preparation.

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413945


Contacts
Contact: Larry S Miller, M.D 718-470-4691 lmiller7@nshs.edu
Contact: Larry S Miller, MD 718-470-4691 lmiller7@nshs.edu

Locations
United States, New York
LIJ Medical Center- NSLIJ Health System Recruiting
New Hyde Park, New York, United States, 11040
Contact: Larry Miller, M.D.    718-470-4691    lmiller7@nshs.edu   
Principal Investigator: Larry Miller, M.D.         
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Larry S Miller, MD Northwell Health
  More Information

Publications:
Responsible Party: Larry Miller, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT01413945     History of Changes
Other Study ID Numbers: 13-216B
First Submitted: August 9, 2011
First Posted: August 10, 2011
Last Update Posted: December 29, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Larry Miller, Northwell Health:
Ileocecal valve
Irritable bowel syndrome
small bowel bacteria

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases