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Prediction of Severity of Liver Disease by a 13C Octanoate Breath Test (OBT)

NCT01244503 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2015-07-28

Study results available
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Summary

The purpose of the study is to demonstrate that the ¹³C-Octanoate Breath Test (OBT) can be used as an aid, in conjunction with other clinical information and medical history, for evaluating disease severity and detecting NASH with a high probability.

Conditions

  • Metabolic Syndrome
  • Nonalcoholic Fatty Liver Disease

Interventions

DRUG

Sodium Octanoate Breath Test

100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed.

Sponsors & Collaborators

  • Meridian Bioscience, Inc.

    collaborator INDUSTRY

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Arun J. Sanyal, M.D. · Virginia Commonwealth University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • United States

Study Locations

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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 NCT01244503 on ClinicalTrials.gov