Constipation Clinical Trial
— WholeGutOfficial title:
Assessment of Whole Gut Transit Time Using the SmartPill Capsule: a Multi-Center Study
Verified date | August 2008 |
Source | The SmartPill Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 178 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Medical Center | Ann Arbor | Michigan |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | VA Medical Center | Buffalo | New York |
United States | University of Iowa | Iowa City | Iowa |
United States | Kansas University Medical Center | Kansas City | Kansas |
United States | Temple University Medical Center | Philadelphia | Pennsylvania |
United States | Mayo Clinic, Scottsdale | Scottsdale | Arizona |
United States | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
The SmartPill Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | whole gut transit time | 2 days and 5 days | No | |
Secondary | Determine regional gut (gastric, small bowel, colonic) transit times | continuous time measure until caspule elimination | No |
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