Transit Time and Bacterial Overgrowth Using SmartPill Capsule

Gastrointestinal Diseases Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

• NCT number: NCT00577772
• Study type: Interventional
• Source: Mayo Clinic
• Status: Terminated
• Phase: N/A
• Start date: November 2007
• Completion date: July 2010