Back to resultsTransit Time and Bacterial Overgrowth Using SmartPill Capsule
Primary Purpose
Small Bowel Bacterial Overgrowth, Gastrointestinal Diseases, Stomach Diseases
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Xifaxan
SmartPill
Lactulose hydrogen breath test (H_2BT)
Sponsored by
About this trial
This is an interventional diagnostic trial for Small Bowel Bacterial Overgrowth focused on measuring SmartPill Capsule, Digestive System Diseases, Small Bowel Bacterial Overgrowth, Gastrointestinal Device, Oro-cecal
Eligibility Criteria
Inclusion Criteria for Healthy Subjects:
- Mentally competent and able to give informed consent.
- Healthy males and females between 18-70 years of age with no current or previous chronic gastrointestinal symptoms.
Inclusion Criteria for Symptomatic Subjects:
- Males and females between 18-70 years of age with symptoms suggestive of small bowel bacterial overgrowth (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months during the previous 12 months (need not be consecutive) who recently underwent an evaluation for small bowel bacterial overgrowth by either hydrogen breath testing or culture of small bowel aspirate.
- Ability to stop laxatives and prokinetic and narcotic analgesic agents 3 days prior to the study and during the study period.
- Ability to stop proton pump inhibitors 7 days prior to the study and histamine type-2 receptor antagonists (H_2RAs) for 3 days prior to the study and during the study period.
Exclusion Criteria:
- 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.
Sites / Locations
- Mayo Clinic Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Healthy Participants
Symptomatic Participants
Arm Description
Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients). The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later. After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days.
Outcomes
Primary Outcome Measures
Oro-cecal Transit Time as Measured by SmartPill
Oro-cecal transit time is the period of time needed by the head of the meal to reach the cecum, which is frequently used as an indicator of small intestinal transit time. Oro-cecal transit was to be determined simultaneously in the study subjects by both the SmartPill technique and the lactulose H_2BT technique.
Secondary Outcome Measures
Full Information
NCT ID
NCT00577772
First Posted
December 17, 2007
Last Updated
October 1, 2012
Sponsor
Mayo Clinic
Collaborators
The SmartPill Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00577772
Brief Title
Transit Time and Bacterial Overgrowth Using SmartPill Capsule
Official Title
An Exploratory Assessment of Small Bowel Transit Time and Small Bowel Bacterial Overgrowth Using the SmartPill Capsule
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Enrollment Goal Not Met
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
The SmartPill Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Bacterial Overgrowth, Gastrointestinal Diseases, Stomach Diseases, Digestive System Diseases
Keywords
SmartPill Capsule, Digestive System Diseases, Small Bowel Bacterial Overgrowth, Gastrointestinal Device, Oro-cecal
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Participants
Arm Type
Active Comparator
Arm Description
Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
Arm Title
Symptomatic Participants
Arm Type
Active Comparator
Arm Description
Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).
The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days.
Intervention Type
Drug
Intervention Name(s)
Xifaxan
Other Intervention Name(s)
Rifaximin
Intervention Description
Open-Label Treatment at 400 mg by mouth, 3 times a day, for 7 days; only for those symptomatic and positive SBBO patients.
Intervention Type
Device
Intervention Name(s)
SmartPill
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lactulose hydrogen breath test (H_2BT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oro-cecal Transit Time as Measured by SmartPill
Description
Oro-cecal transit time is the period of time needed by the head of the meal to reach the cecum, which is frequently used as an indicator of small intestinal transit time. Oro-cecal transit was to be determined simultaneously in the study subjects by both the SmartPill technique and the lactulose H_2BT technique.
Time Frame
baseline to passage of SmartPill, passage of SmartPill estimated no more than 72 hours from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Healthy Subjects:
Mentally competent and able to give informed consent.
Healthy males and females between 18-70 years of age with no current or previous chronic gastrointestinal symptoms.
Inclusion Criteria for Symptomatic Subjects:
Males and females between 18-70 years of age with symptoms suggestive of small bowel bacterial overgrowth (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months during the previous 12 months (need not be consecutive) who recently underwent an evaluation for small bowel bacterial overgrowth by either hydrogen breath testing or culture of small bowel aspirate.
Ability to stop laxatives and prokinetic and narcotic analgesic agents 3 days prior to the study and during the study period.
Ability to stop proton pump inhibitors 7 days prior to the study and histamine type-2 receptor antagonists (H_2RAs) for 3 days prior to the study and during the study period.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John K. DiBaise, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
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Transit Time and Bacterial Overgrowth Using SmartPill Capsule
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