NCT00577772

Transit Time and Bacterial Overgrowth Using SmartPill Capsule

An Exploratory Assessment of Small Bowel Transit Time and Small Bowel Bacterial Overgrowth Using the SmartPill Capsule

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Small bowel bacterial overgrowth (SBBO), an increasingly recognized malabsorptive condition caused by the excessive growth of bacteria in the small bowel, results in a spectrum of symptoms such as diarrhea, bloating abdominal discomfort and weight loss. Multiple factors both internal and external to the individual prevent excessive small bowel bacterial colonization and determine the types of bacteria present. The most important factors within the individual are normal small bowel motility, which prevents attachment of ingested organisms, and gastric acid, which destroys many organisms before they reach the small intestine. The determination of small bowel motility is problematic due to limitations of the tests available (e.g., hydrogen breath test, scintigraphy and manometry). The SmartPill capsule is a recently developed novel device that, following its ingestion, can measure pH, pressure and temperature as it moves through the gastrointestinal tract. These recordings can be used to measure gastrointestinal transit and, potentially, other aspects of gastrointestinal motility/function. Previous studies using this device have demonstrated the ability of the SmartPill to measure the gastric residence time using the duration of acidic pH recording with good correlation between the gastric residence time of the SmartPill capsule and conventional gastric emptying scintigraphy.

Conditions

• Small Bowel Bacterial Overgrowth
• Gastrointestinal Diseases
• Stomach Diseases
• Digestive System Diseases

Interventions

Type	Name	Description
DRUG	Xifaxan	Open-Label Treatment at 400 mg by mouth, 3 times a day, for 7 days; only for those symptomatic and positive SBBO patients.
DEVICE	SmartPill	The SmartPill is a single-use, ingestible capsule that utilizes sensor technology to measure pressure, pH and temperature throughout the entire GI tract. The ACT-1 (SmartPill) GI Monitoring System includes an ingestible capsule, a receiver and video display software.
PROCEDURE	Lactulose hydrogen breath test (H_2BT)	A hydrogen breath test provides information about the digestion of certain sugars or carbohydrates, such as milk sugar (lactose) or fruit sugar (fructose). The test is also used for detecting abnormal growth of bacteria within the small bowel by having the patient ingest lactulose.

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2007-12-20
• Last updated: 2012-10-05
• Results posted: 2012-10-01

Locations

1 site across 1 country: United States