Ileocecal Sphincter Reflex by Cecal Distension During Colonoscopy
| Status: | Terminated |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 20 - 80 |
| Updated: | 2/24/2019 |
| Start Date: | June 21, 2013 |
| End Date: | January 18, 2017 |
Evaluation of the Ileocecal Valve in Patients With and Without Irritable Bowel Syndrome.(IBS)
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.
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.
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.
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.
We found this trial at
1
site
New Hyde Park, New York 11040
Principal Investigator: Larry Miller, M.D.
Phone: 718-470-4691
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