Transit Time and Bacterial Overgrowth Using SmartPill Capsule

Not Applicable

Terminated

Conditions: Small Bowel Bacterial Overgrowth
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases

Interventions: Drug: Xifaxan
Procedure: Lactulose hydrogen breath test (H_2BT)
Device: SmartPill

Registration Number: NCT00577772

Lead Sponsor: Mayo Clinic

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 17

Inclusion Criteria

Not provided

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Participants	Lactulose hydrogen breath test (H_2BT)	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.
Symptomatic Participants	SmartPill	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.
Healthy Participants	SmartPill	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.
Symptomatic Participants	Lactulose hydrogen breath test (H_2BT)	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.
Symptomatic Participants	Xifaxan	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.

Primary Outcome Measures

Name	Time	Method
Oro-cecal Transit Time as Measured by SmartPill	baseline to passage of SmartPill, passage of SmartPill estimated no more than 72 hours from baseline	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