Clinical trials: Breath Test
Congenital Sucrase-isomaltase Deficiency (CSID)
Congenital Sucrase-Isomaltase Deficiency (CSID) Genetic Prevalence Study (GPS)
Congenital sucrose-isomaltase deficiency (CSID) is a rare, genetic disease in which mutations in the sucrose-isomaltase (SI) gene cause digestion problems of sucrose resulting in diarrhea and abdominal pain.
- Trial name
- CSID GPS (NCT01914003)
- Where
- 19 sites in United States
- Volunteers
- 53 people
- Sponsor
- QOL Medical, LLC
NASH - Nonalcoholic Steatohepatitis, Cirrhosis
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14
To validate the ability of the Methacetin Breath Test (MBT) to detect clinically significant portal hypertension (CSPH)/severe portal hypertension (SPH) defined as hepatic venous pressure gradient (HVPG) ≥ 10 mmHg and HVPG ≥ 12…
- Conditions
- NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Portal Hypertension
- Trial name
- NCT03439189
- Testing
- Methacetin Breath Test, Emricasan
- Where
- France
- Volunteers
- 343 people
- Sponsor
- Meridian Bioscience, Inc.
Helicobacter Pylori Infection
Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection
The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori…
- Trial name
- NCT02528721
- Testing
- Dual Mode BreathID Hp System
- Where
- 13 sites in United States, Israel
- Volunteers
- 282 people
- Sponsor
- Meridian Bioscience, Inc.
Chronic Liver Disease, Hepatocellular Carcinoma (HCC)
Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI
The Exalenz clinical investigation is a multicenter, non-randomized, study of the ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to evaluate the capability of the OBT measurement to…
- Trial name
- OBT for HCC (NCT01433016)
- Testing
- 13C Sodium Octanoate
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Meridian Bioscience, Inc.
Gastroparesis
Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis
GSK962040 is a novel small molecule motilin agonist. The Phase I studies (MOT107043 and MOT109681) demonstrated that single doses of GSK962040 up to 150 mg and repeat dosing of up to 125 mg/day for 14 days were well tolerated…
- Trial name
- NCT01262898
- Testing
- GSK962040 (5 mg tablet), GSK962040 (25 mg tablet), GSK962040 (125 mg tablet)
- Where
- 22 sites in United States, Australia and 4 more
- Volunteers
- 79 people
- Sponsor
- GlaxoSmithKline
H. Pylori Infection
ARJ C13 Urea Breath Test System
An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea Breath Test to predicate devices on the market.
- Trial name
- NCT04036838
- Testing
- PyloPlus UBT System, Histology, Rapid Urease Test
- Where
- 6 sites in United States
- Volunteers
- 415 people
- Sponsor
- ARJ Medical, Inc.
Patients With Compensated Liver Cirrhosis
Assessing Portal Hypertension With Methacetin Breath Test
This study will be used to train an algorithm using Methacetin breath test (MBT) measures and to select a cut-off to determine presence or absence of Clinically Significant Portal Hypertension (CSPH) as defined by Hepatic Venous…
- Trial name
- NCT02143778
- Testing
- Methacetin Breath Test
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 246 people
- Sponsor
- Meridian Bioscience, Inc.
Non-Alcoholic Steatohepatitis
BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH
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…
- Trial name
- NCT02314026
- Testing
- Suspected NASH BreathID test with 13C-Octanoate, Suspected NASH Breath test with 13C Methacetin
- Where
- 11 sites in United States, Belgium and 2 more
- Volunteers
- 140 people
- Sponsor
- Meridian Bioscience, Inc.
Helicobacter Pylori Infection
Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics
Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
- Trial name
- NCT02905825
- Testing
- BreathID® Hp System, BreathID® Hp Lab System, Stool Test
- Where
- 6 sites in United States, Israel
- Volunteers
- 54 people
- Sponsor
- Meridian Bioscience, Inc.
NASH - Nonalcoholic Steatohepatitis
Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials
This is a companion study assessing the ¹³C-Methacetin Breath Test (MBT) in subjects participating in the Bristol Myers-Squibb (BMS) NCT03486899 and NCT03486912 referenced studies using study drug BMS-986036.
- Trial name
- NCT03611101
- Testing
- ¹³C-Methacetin Breath Test, BMS-986036, BreathID MCS device
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Meridian Bioscience, Inc.
Decompensated Cirrhosis
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17
This study is a companion protocol that will use the data generated by Conatus' study of emricasan under protocol IDN-6556-17.The IDN-6556-17 study is a Phase 2, multicenter, double-blind, placebo-controlled trial of Emricasan in…
- Trial name
- NCT03462576
- Testing
- Methacetin Breath Test, Emricasan
- Where
- United States
- Volunteers
- 199 people
- Sponsor
- Meridian Bioscience, Inc.
Gastroparesis
GEBT Telehealth Administration Usability Study
The purpose of this study is to establish the usability of a telehealth platform for the administration of GEBT.
- Trial name
- NCT04684992
- Testing
- GEBT Telehealth Administration Usability
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Cairn Diagnostics
Chronic Liver Disease
BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
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.
- Trial name
- MBT (NCT00736840)
- Testing
- c13 methacetin solution with breath analyzer
- Where
- 11 sites in United States, Israel
- Volunteers
- 414 people
- Sponsor
- Meridian Bioscience, Inc.
Suspicion of Being Infected With H.Pylori
Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection
The purpose of this study is to confirm equivalence of a new generation breath analyzer (Modified BreathID) in its ability to detect H. pylori compared to the currently approved BreathID® System.
- Trial name
- NCT01650831
- Testing
- Modified BreathID
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Meridian Bioscience, Inc.
Helicobacter Pylori Infection
13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)
Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive.
- Trial name
- NCT00825630
- Testing
- Lansoprazole (Lanton), Omeprezole (Losec), Pantoprazole(Controloc)
- Where
- Israel
- Volunteers
- 123 people
- Sponsor
- Meridian Bioscience, Inc.
Chronic Liver Disease
Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation
The objectives of this study are: To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT…
- Trial name
- NCT02084160
- Where
- 4 sites in United States, Israel
- Volunteers
- 579 people
- Sponsor
- Meridian Bioscience, Inc.
Lactose Intolerance
HYBRID: Hydrogen Breath Test in Lactose Digestion
The purpose of this study is to investigate the effect of a fermented infant formula on lactose digestion in lactose intolerant adults.
- Trial name
- HYBRID (NCT02703987)
- Testing
- Fermented infant milk formula, Non-fermented infant milk formula
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.