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BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH

NCT02314026 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-12-20

Study results available
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Summary

This study's aim is to develop an algorithm for the ¹³C-Octanoate Breath Test with or without the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological findings associated with of Non-Alcoholic Steatohepatitis (NASH) and other liver diseases using the BreathID® System

Conditions

  • Non-Alcoholic Steatohepatitis

Interventions

DEVICE

Suspected NASH BreathID test with 13C-Octanoate

Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water

DEVICE

Suspected NASH Breath test with 13C Methacetin

Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water

Sponsors & Collaborators

  • Meridian Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Yaron Ilan, M.D. · Hadassah Medical Organization

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States
  • Belgium
  • France
  • United Kingdom

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 NCT02314026 on ClinicalTrials.gov