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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00577772
• Other study ID #: 06-002721
• Status: Terminated
• Phase: N/A
• First received: December 17, 2007
• Last updated: October 1, 2012
• Start date: November 2007
• Est. completion date: July 2010

Study information

• Verified date: October 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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 information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

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 histamine type-2 receptor antagonists (H_2RAs) for 3 days prior to the study and during the study period.

Exclusion Criteria:

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 and fundoplication).

3. Hypersensitivity to rifaximin.

4. Use of any medications in the previous week that could alter gastrointestinal motor function.

5. Body Mass Index (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 capsule ingestion).

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.

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

Intervention

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.

Device:
• SmartPill
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.

Procedure:
• Lactulose hydrogen breath test (H_2BT)
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.

Locations

Country	Name	City	State
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	The SmartPill Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline to passage of SmartPill, passage of SmartPill estimated no more than 72 hours from baseline	No