Pilot Study Using a Wireless Motility Capsule
Research suggests dietary fiber may decrease transit time through the gastrointestinal tract. Research studies traditionally use radio-opaque markers to determine gastric emptying, colonic transit, and whole gut transit time. The SmartPill is a single use pill that can be used to determine gastric emptying, colonic transit, and whole gut transit time without requiring X-rays or fecal collections. Previous studies have found radio-opaque markers and the SmartPill detect the similar transit times.
The purpose of this pilot study is to determine if the SmartPill can detect a change in transit time using a significant dose of dietary fiber.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
|Official Title:||Measurement of Whole Gut Transit Time After a Dietary Fiber Treatment Using a Wireless Motility Capsule|
- Whole Gut Transit Time [ Time Frame: 5 days ] [ Designated as safety issue: No ]The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.
- Gastrointestinal Tolerance [ Time Frame: Day 4 ] [ Designated as safety issue: No ]Subjects scored their gastrointestinal tolerance based on 7 questions on a 0-10 scale on day 4 of each treatment period and the sum score was reported. 0 being the best and 10 being the worst. Each question has a value of 1-10 for a total of 70 points as value.
- Food Intake Diary [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Total dietary fiber consumed.
|Study Start Date:||August 2009|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: Low fiber and High Fiber
Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102894
|United States, Minnesota|
|University of Minnesota - McNeal Hall|
|St. Paul, Minnesota, United States, 55108|
|Principal Investigator:||Joanne L Slavin, PhD||University of Minnesota - Clinical and Translational Science Institute|