Assessment of the Whole Gut Transit Time Using the SmartPill Capsule (HUM0004866)

Principal Investigator: Richard Saad, MD
Contact: Borko Nojkov, 734-936-8750, bnojkov@med.umich.edu

Study Purpose:
To compare two methods of measuring motility of the gastrointestinal tract for patients with constipation as compared to healthy controls.

Study Description:
Multicenter Study. A novel technology, named the SmartPill GI Monitoring System, measures intraluminal gastrointestinal pH, pressure and temperature. Through such measurements, gastrointestinal transit can be determined. This study is being done to compare this non-invasive method to the conventional Sitzmark radiopaque markers test in healthy subjects and patients with constipation. Subjects will undergo a screening visit to verify eligibility. There are at least 3 visits. The testing visit will last up to 8 hours, and the 2 follow-up visits will last approximately 1 hour.

Eligibility:

• Males and females 65-80 years old
• Both healthy subjects and patients with chronic constipation
• Constipated subjects must have at least 3 bowel movements per week
• Females must be practicing effective birth control and must not be pregnant or lactating
• No abdominal surgery within last 3 months
• No history of diverticulitis, diverticular stricture, and other intestinal strictures
• No medications that affect gastrointestinal motility for 3 days prior to testing and throughout
• No medications that may alter gastric pH taken during study
• No tobacco, alcohol within 8 hours prior to testing and throughout monitoring period (up to 5 days)
• No use of medical devices such as pacemakers, infusion pumps, insulin pumps
• Symptoms must be for at least 1 year duration.

Compensation:
$400 for completing the study