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Assessment of Whole Gut Transit Time Using the SmartPill Capsule (WholeGut)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603707
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : August 29, 2008
Information provided by:
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.

Condition or disease

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.

Study Type : Observational
Actual Enrollment : 178 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Whole Gut Transit Time Using the SmartPill Capsule: a Multi-Center Study
Study Start Date : October 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

healthy adult subjects with no history or current gastrointestinal disorders or conditions
Adult subjects with functional constipation as define by Rome II criteria

Primary Outcome Measures :
  1. whole gut transit time [ Time Frame: 2 days and 5 days ]

Secondary Outcome Measures :
  1. Determine regional gut (gastric, small bowel, colonic) transit times [ Time Frame: continuous time measure until caspule elimination ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with constipation referred to a tertiary motility center

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00603707

United States, Arizona
Mayo Clinic, Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, New York
VA Medical Center
Buffalo, New York, United States, 14215
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Temple University Medical Center
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
The SmartPill Corporation
Study Chair: Henry Parkman, MD Temple University Medical Center

Responsible Party: John R. Semler/Chief Technology Officer, The SmartPill Corporation Identifier: NCT00603707     History of Changes
Other Study ID Numbers: 122205
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: August 29, 2008
Last Verified: August 2008

Keywords provided by The SmartPill Corporation:
whole gut transit
colonic transit
gastric emptying
small bowel transit

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms