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.
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.
Inclusion Criteria for Healthy Subjects:
1. Mentally competent and able to give informed consent.
2. Healthy males and females between 18-70 years of age with no current or previous
chronic gastrointestinal symptoms.
Inclusion Criteria for Symptomatic Subjects:
1. 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 at MCS.
2. Ability to stop laxatives and prokinetic and narcotic analgesic agents 3 days prior
to the study and during the study period.
3. Ability to stop proton pump inhibitors 7 days prior to the study and H2RAs for 3 days
prior to the study and during the study period.
1. Subjects who are unable or unwilling to give informed consent or return for all
required study visits.
2. Prior gastrointestinal surgery which has altered the anatomy of the esophagus,
stomach or small/large intestine (exceptions include appendectomy, cholecystectomy
3. Hypersensitivity to rifaximin.
4. Use of any medications in the previous week that could alter gastrointestinal motor
5. BMI > 38.
6. Previous history of bezoars.
7. Any abdominal surgery within the past 3 months.
8. Known or history of inflammatory bowel disease.
9. History of diverticulitis, diverticular stricture, and other intestinal strictures.
10. Tobacco use within eight hours prior to capsule ingestion and during the initial 8
hour recording on the first day.
11. Alcohol use within eight hours prior to capsule ingestion and throughout the entire
monitoring period (up to 5 days).
12. 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
13. Cardiovascular, endocrine, renal or other chronic disease likely to affect motility.
14. Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.