This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
144
patients will receive vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
patients will receive sham non-vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
Borland-Groover Clinic
Jacksonville, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
Frequency of bowel movements
change from baseline in the weekly Spontaneous Bowel Movement (SBM) rate during treatment period. Success will be defined as increase by at least 1 SBM/week. The primary analysis will be a comparative analysis of success rates between the study groups
Time frame: 3 months
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MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Mgh Boston
Boston, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Albuquerque Neuroscience
Albuquerque, New Mexico, United States
NYU Langone Medical Center
New York, New York, United States
Temple University School of Medicine
Philadelphia, Pennsylvania, United States
CTRS LLC
Pittsburgh, Pennsylvania, United States
...and 8 more locations