Clinical trial NCT00603707: Assessment of Whole Gut Transit Time Using the SmartPill Capsule
Official title: Assessment of Whole Gut Transit Time Using the SmartPill Capsule: a Multi-Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
Keywords: capsule
constipation
whole gut transit
colonic transit
gastric emptying
small bowel transit
Lead sponsor: The SmartPill Corporation
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with constipation referred to a tertiary motility center

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.

Eligibility 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.

Primary outcomes:
measure: whole gut transit time
timeFrame: 2 days and 5 days
Secondary outcomes:
measure: Determine regional gut (gastric, small bowel, colonic) transit times
timeFrame: continuous time measure until caspule elimination
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic, Scottsdale
state: Arizona
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Buffalo
country: United States
facility: VA Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Medical Center
state: Pennsylvania
Study officials:
affiliation: Temple University Medical Center
name: Henry Parkman, MD
role: STUDY_CHAIR
References: