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

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.