Transit Time and Bacterial Overgrowth Using SmartPill Capsule

This study has been terminated.
(Enrollment Goal Not Met)
Sponsor:
Collaborator:
The SmartPill Corporation
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00577772
First received: December 17, 2007
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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
Small Bowel Bacterial Overgrowth
Gastrointestinal Diseases
Stomach Diseases
Digestive System Diseases
Drug: Xifaxan
Device: SmartPill
Procedure: Lactulose hydrogen breath test (H_2BT)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Exploratory Assessment of Small Bowel Transit Time and Small Bowel Bacterial Overgrowth Using the SmartPill Capsule

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Oro-cecal Transit Time as Measured by SmartPill [ Time Frame: baseline to passage of SmartPill, passage of SmartPill estimated no more than 72 hours from baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 17
Study Start Date: November 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy Participants
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.
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.
Active Comparator: Symptomatic Participants

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.

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.
Other Name: Rifaximin
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577772

Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
The SmartPill Corporation
Investigators
Principal Investigator: John K. DiBaise, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: John DiBaise, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00577772     History of Changes
Other Study ID Numbers: 06-002721
Study First Received: December 17, 2007
Results First Received: August 30, 2012
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
SmartPill Capsule
Digestive System Diseases
Small Bowel Bacterial Overgrowth
Gastrointestinal Device
Oro-cecal

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Rifaximin
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 25, 2014