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Transit Time and Bacterial Overgrowth Using SmartPill Capsule

NCT00577772 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2012-10-05

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • The SmartPill Corporation

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • John K. DiBaise, M.D. · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00577772 on ClinicalTrials.gov