The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCam® procedure, colon cleanliness and capsule excretion time.
Interim analysis will be done after 20 subjects are enrolled in order to assess the 1st arm. Following the analysis of the first phase results, and per need, 30 more subjects may be enrolled under a different regimen (2nd arm). Second Interim analysis will be done in order to assess the 2nd phase results. Following the analysis of the 2nd phase results, and per need, up to 30 additional subjects may be enrolled under a third regimen (3rd arm).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
80
Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take MgC boosts.
Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take Suprep boosts
Alabama Digestive Disorders Center
Huntsville, Alabama, United States
Division of Gastroenterology Indiana University Medical Center
Indianapolis, Indiana, United States
Research Associates of New York
New York, New York, United States
University of North Carolina Division of Digestive Disease
Chapel Hill, North Carolina, United States
Capsule excretion rate
Time frame: 10 hours post capsule ingestion
Distribution of PillCam® COLON 2 excretion times
Time frame: Up to 12 hours and at least 12 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take reduced dose of Suprep boosts
Digestive Care, Inc.
Beavercreek, Ohio, United States
Franklin Gastroenterology
Franklin, Tennessee, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States