Ileocecal Sphincter Reflex by Cecal Distension During Colonoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Temple University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT01413945
First received: August 9, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

To measure the pressure of the ileocecal valve (ICV) and define the patterns of Cecal/ICV reflex


Condition
Colonoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Pressure generated in ICV during Cecal distention [ Time Frame: 10-15 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal volunteers during screening endoscopy
Volunteers with problems of ICV

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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 SBBO 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413945

Contacts
Contact: Larry S Miller, M.D 215-707-9985 vivi@temple.edu

Locations
United States, Pennsylvania
Temple U niversity Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Larry S Miller, M.D.    215-707-9985    vivi@temple.edu   
Principal Investigator: Larry S Miller, M.D         
Sponsors and Collaborators
Temple University
  More Information

Publications:

Responsible Party: Dr. Larry Miller, Professor of Medicine, Temple University
ClinicalTrials.gov Identifier: NCT01413945     History of Changes
Other Study ID Numbers: R01 DK079954-02_ICV, R01DK079954-02
Study First Received: August 9, 2011
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Temple University:
Identifying the physiology and pathology of ileocecal valve

ClinicalTrials.gov processed this record on July 29, 2014