Assessment of Whole Gut Transit Time Using the SmartPill Capsule
NCT ID: NCT00603707
Last Updated: 2008-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
178 participants
OBSERVATIONAL
2006-10-31
2008-06-30
Brief Summary
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Detailed Description
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Both techniques are simultaneously applied in normal and constipated adult populations.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Normal
healthy adult subjects with no history or current gastrointestinal disorders or conditions
No interventions assigned to this group
Constipated
Adult subjects with functional constipation as define by Rome II criteria
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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The SmartPill Corporation
INDUSTRY
Responsible Party
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The SmartPill Corporation
Principal Investigators
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Henry Parkman, MD
Role: STUDY_CHAIR
Temple University Medical Center
Locations
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Mayo Clinic, Scottsdale
Scottsdale, Arizona, United States
University of Iowa
Iowa City, Iowa, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
VA Medical Center
Buffalo, New York, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Temple University Medical Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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122205
Identifier Type: -
Identifier Source: org_study_id