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

The SmartPill Corporation

Status: Completed

Conditions: Constipation

Study type: Observational

Funder types: Industry

Identifiers

NCT00603707

122205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

178 participants in 2 patient groups

Normal

Description:

healthy adult subjects with no history or current gastrointestinal disorders or conditions

Constipated

Description:

Adult subjects with functional constipation as define by Rome II criteria