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Sponsors and Collaborators: |
Mayo Clinic The SmartPill Corporation |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00577772 |
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.
Condition | Intervention |
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Small Bowel Bacterial Overgrowth Gastrointestinal Diseases Stomach Diseases Digestive System Diseases |
Drug: Xifaxan |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | An Exploratory Assessment of Small Bowel Transit Time and Small Bowel Bacterial Overgrowth Using the SmartPill Capsule |
Estimated Enrollment: | 20 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Healthy: No Intervention
Healthy Volunteers
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Symptomatic
5 SBBO positive patients, 5 SBBO negative patients
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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.
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for Healthy Subjects:
Inclusion Criteria for Symptomatic Subjects:
Exclusion Criteria:
United States, Arizona | |
Mayo Clinic Arizona | |
Scottsdale, Arizona, United States, 85259 |
Principal Investigator: | John K. DiBaise, M.D. | Mayo Clinic |
Responsible Party: | Mayo Clinic ( John DiBaise, M.D. ) |
Study ID Numbers: | 06-002721 |
Study First Received: | December 17, 2007 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00577772 History of Changes |
Health Authority: | United States: Institutional Review Board |
SmartPill Capsule Digestive System Diseases Small Bowel Bacterial Overgrowth Gastrointestinal Device |
Digestive System Diseases Stomach Diseases Gastrointestinal Diseases Rifaximin |
Stomach Diseases Digestive System Diseases Gastrointestinal Diseases |