BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis (MBT)

Meridian Bioscience

Status and phase

Completed

Phase 3

Conditions

Chronic Liver Disease

Treatments

Device: c13 methacetin solution with breath analyzer

Study type

Interventional

Funder types

Industry

Identifiers

NCT00736840

HIS-EX-408

Details and patient eligibility

About

This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.

Full description

Patients with chronic liver disease who have a recent biopsy will be offered a breath test. Correlation will be shown between histology and breath test in determining cirrhosis.

Enrollment

414 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >18 with chronic liver disease

Exclusion criteria

Patients that are taking hepatotoxin drug.
Patient with severe congestive heart failure
Patient with severe pulmonary hypertension
Patient with uncontrolled diabetes mellitus
Patient with previous surgical bypass surgery for morbid obesity
Patient with extensive small bowel resection
Patient currently receiving total parenteral nutrition
Patient is a recipients of any organ transplant
Patients that received any anti-viral treatment within the past year
Women who are pregnant
Patient allergic to acetaminophen (such as Tylenol or any other related medications)
Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma
Patients unable to sign informed consent
Patients that based on the opinion of the investigator should not be enrolled into this study
Patients that are participating in other clinical trials evaluating experimental treatments or procedures