Assessment of Whole Gut Transit Time Using the SmartPill Capsule

Completed

Conditions studied: Constipation

In brief

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.

Key facts

Study ID

NCT00603707

Run by

The SmartPill Corporation

People needed

178

Starts

2006-10-01

Expected to finish

2008-06-01

Last updated by the study team

2008-08-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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