Trial record 1 of 1 for:    NCT00603707
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Assessment of Whole Gut Transit Time Using the SmartPill Capsule (WholeGut)

This study has been completed.
Sponsor:
Information provided by:
The SmartPill Corporation
ClinicalTrials.gov Identifier:
NCT00603707
First received: January 8, 2008
Last updated: August 28, 2008
Last verified: August 2008
  Purpose

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 Phase
Constipation
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Whole Gut Transit Time Using the SmartPill Capsule: a Multi-Center Study

Resource links provided by NLM:


Further study details as provided by The SmartPill Corporation:

Primary Outcome Measures:
  • whole gut transit time [ Time Frame: 2 days and 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine regional gut (gastric, small bowel, colonic) transit times [ Time Frame: continuous time measure until caspule elimination ] [ Designated as safety issue: No ]

Enrollment: 178
Study Start Date: October 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal
healthy adult subjects with no history or current gastrointestinal disorders or conditions
Constipated
Adult subjects with functional constipation as define by Rome II criteria

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients with constipation referred to a tertiary motility center

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603707

Locations
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
Investigators
Study Chair: Henry Parkman, MD Temple University Medical Center
  More Information

No publications provided

Responsible Party: John R. Semler/Chief Technology Officer, The SmartPill Corporation
ClinicalTrials.gov Identifier: NCT00603707     History of Changes
Other Study ID Numbers: 122205
Study First Received: January 8, 2008
Last Updated: August 28, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 29, 2014