Pilot Study Using a Wireless Motility Capsule
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|ClinicalTrials.gov Identifier: NCT01102894|
Recruitment Status : Completed
First Posted : April 13, 2010
Results First Posted : October 27, 2014
Last Update Posted : November 4, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Food Selection||Device: SmartPill||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Measurement of Whole Gut Transit Time After a Dietary Fiber Treatment Using a Wireless Motility Capsule|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
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
- Whole Gut Transit Time [ Time Frame: 5 days ]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 ]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 ]Total dietary fiber consumed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|