Assessment of Whole Gut Transit Time Using the SmartPill Capsule
- Conditions
- Constipation
- Registration Number
- NCT00603707
- Lead Sponsor
- The SmartPill Corporation
- Brief Summary
Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and SmartPill) are equivalent and is demonstrated if the study population shows a correlation of 0.7 or higher.
- Detailed Description
The purpose of the study is to measure total gastrointestinal transit time using SmartPill GI Monitoring System with pH.p Capsule and compare the transit time determined by capsule transit to the conventional radioopaque marker technique.
Both techniques are simultaneously applied in normal and constipated adult populations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 178
- Males and females between ages of 18-80 years of age with functional constipation that fulfills the Rome II definition of functional constipation
- Bowel movement frequency of < 3 times per week but at least once per two weeks.
- Constipation symptoms for at least 1 year duration.
- Constipation, not abdominal pain, as the primary symptom.
- Ability to stop fiber, laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to the study and during the 5 day study period.
- Ability to stop proton pump inhibitors 7 days prior to the study and H2RAs for 3 days prior to the study.
- Previous history of bezoars.
- Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
- Any abdominal surgery within the past 3 months
- Known or history of inflammatory bowel disease
- History of diverticulitis, diverticular stricture, and other intestinal strictures
- Tobacco use within eight hours prior to capsule ingestion and during the initial 8 hour recording on Day 0 or the Ingestion visit.
- Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (5 days).
- BMI > 38
- Allergies to components of the SmartBar (Appendix IX).
- Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. (A urine pregnancy test will be performed on female subjects prior to capsule ingestion).
- Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
- Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.
- Any contraindication to use of Fleets Enema or balloon expulsion test.
- Uncontrolled diabetes with a hemoglobin A1C greater than 10.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method whole gut transit time 2 days and 5 days
- Secondary Outcome Measures
Name Time Method Determine regional gut (gastric, small bowel, colonic) transit times continuous time measure until caspule elimination
Trial Locations
- Locations (8)
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Mayo Clinic, Scottsdale
🇺🇸Scottsdale, Arizona, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
VA Medical Center
🇺🇸Buffalo, New York, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Temple University Medical Center
🇺🇸Philadelphia, Pennsylvania, United States