Ileocecal Sphincter Reflex by Cecal Distension During Colonoscopy

Irritable Bowel Syndrome Clinical Trial

Official title:

Evaluation of the Ileocecal Valve in Patients With and Without Irritable Bowel Syndrome.(IBS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01413945
• Other study ID #: 13-216B
• Status: Terminated
• Start date: June 21, 2013
• Est. completion date: January 18, 2017

Study information

• Verified date: February 2019
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 18, 2017
• Est. primary completion date: August 5, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	LIJ Medical Center- NSLIJ Health System	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (11)

Castell DO, Cohen S, Harris LD. Response of human ileocecal sphincter to gastrin. Am J Physiol. 1970 Sep;219(3):712-5. — View Citation

Cohen S, Harris LD, Levitan R. Manometric characteristics of the human ileocecal junctional zone. Gastroenterology. 1968 Jan;54(1):72-5. — View Citation

GAZET RJ, JARRETT J. THE ILEOCAECO-COLIC SPHINCTER. STUDIES IN VITRO IN MAN, MONKEY, CAT, AND DOG. Br J Surg. 1964 May;51:368-70. — View Citation

Griffen WO Jr, Richardson JD, Medley ES. Prevention of small bowel contamination by ileocecal valve. South Med J. 1971 Sep;64(9):1056-8. — View Citation

Jarrett RJ, Gazet JC. Studies in vivo of the ileocaeco-colic sphincter in the cat and dog. Gut. 1966 Jun;7(3):271-5. — View Citation

Kelley ML Jr, Gordon EA, Deweese JA. Pressure responses of canine ileocolonic junctional zone to intestinal distention. Am J Physiol. 1966 Sep;211(3):614-8. — View Citation

King CE, Toskes PP. Small intestine bacterial overgrowth. Gastroenterology. 1979 May;76(5 Pt 1):1035-55. — View Citation

Pahlin PE, Kewenter J. Sympathetic nervous control of cat ileocecal sphincter. Am J Physiol. 1976 Aug;231(2):296-305. — View Citation

Rubin MR, Fournet J, Snape WJ Jr, Cohen S. Adrenergic regulation of ileocecal sphincter function in the cat. Gastroenterology. 1980 Jan;78(1):15-21. — View Citation

SINGLETON AO Jr, REDMOND DC 2nd, MCMURRAY JE. ILEOCECAL RESECTION AND SMALL BOWEL TRANSIT AND ABSORPTION. Ann Surg. 1964 May;159:690-4. — View Citation

Stremmel W, Kurpreugsch K, Langewitz W. [Hormonal and pharmacological modification of the ileocecal sphincter]. Chir Forum Exp Klin Forsch. 1977 Apr:45-8. German. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure generated in ICV during Cecal distention		10-15 minutes