Transit Time and Bacterial Overgrowth Using SmartPill Capsule

Stopped early · Not applicable

Conditions studied: Small Bowel Bacterial Overgrowth, Gastrointestinal Diseases, Stomach Diseases, Digestive System Diseases

In brief

The primary purpose of this exploratory study is to measure orocecal transit time using the SmartPill ambulant capsule technology and to compare this with the lactulose hydrogen breath test. Additionally, the ability of the SmartPill GI Monitoring System to discriminate between healthy human subjects and patients with small bowel bacterial overgrowth will be explored using analyses of both pH and pressure patterns within the stomach and small intestine. The study will be performed in both normal subjects and patients with and without small bowel bacterial overgrowth.

Key facts

Study ID

NCT00577772

Run by

Mayo Clinic

People needed

17

Starts

2007-11-01

Expected to finish

2010-07-01

Last updated by the study team

2012-10-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Subjects who are unable or unwilling to give informed consent or return for all required study visits.
• Prior gastrointestinal surgery which has altered the anatomy of the esophagus, stomach or small/large intestine (exceptions include appendectomy, cholecystectomy and fundoplication).
• Hypersensitivity to rifaximin.
• Use of any medications in the previous week that could alter gastrointestinal motor function.
• Body Mass Index (BMI) > 38.
• Previous history of bezoars.
• 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 the first day.
• Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (up to 5 days).
• 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.

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.