Transit Time and Bacterial Overgrowth Using SmartPill Capsule

NCT00577772 | Terminated Results

• 1 other identifier: 06-002721
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Healthy Participants

ACTIVE COMPARATOR

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; Procedure: Lactulose hydrogen breath test (H_2BT)

Symptomatic Participants

ACTIVE COMPARATOR

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; Device: SmartPill; Procedure: Lactulose hydrogen breath test (H_2BT)

Interventions

Xifaxan DRUG

Open-Label Treatment at 400 mg by mouth, 3 times a day, for 7 days; only for those symptomatic and positive SBBO patients.

Also known as: Rifaximin

Symptomatic Participants

SmartPill DEVICE

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.

Healthy Participants; Symptomatic Participants

Lactulose hydrogen breath test (H_2BT) PROCEDURE

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.

Healthy Participants; Symptomatic Participants

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• The SmartPill Corporation: collaborator

Study Sites (1)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Stomach Diseases; Digestive System Diseases

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

The study was terminated early because enrollment goals were not met.

Results Point of Contact

• Title: Dr. John K. DiBaise
• Organization: Mayo Clinic

dibaise.john@mayo.edu

480-301-6990

Study Officials

• John K. DiBaise, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 20, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 5, 2012
• Results First Posted: October 1, 2012

Record last verified: 2012-10

Locations

US (1)