Clinical trials: Breath Analysis
Metabolic Syndrome, Nonalcoholic Fatty Liver Disease
Prediction of Severity of Liver Disease by a 13C Octanoate Breath Test (OBT)
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…
- Trial name
- NCT01244503
- Testing
- Sodium Octanoate Breath Test
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- Virginia Commonwealth University
Colorectal Cancer, Colorectal Polyps
The Colorectal Breath Analysis (COBRA) Study
This study aims to determine whether a breath test could be used for early detection of colorectal cancer and colorectal polyps.
- Conditions
- Colorectal Cancer, Colorectal Polyps, Colorectal Adenocarcinoma
- Trial name
- COBRA (NCT03699163)
- Testing
- Breath sample
- Where
- 8 sites in United Kingdom
- Volunteers
- 1,855 people
- Sponsor
- Imperial College London
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.
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.
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.
Celiac Disease
Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease
Celiac disease is a condition in which the small intestine is damaged by gluten, the storage protein of wheat and similar proteins in barley and rye.
- Trial name
- NCT01137955
- Testing
- Rifaximin
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
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.
Dyspepsia
Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath test and scintigraphy in healthy subjects and subjects with dyspepsia.
- Trial name
- NCT01248221
- Testing
- [13C]-Spirulina platensis and 99mTc sulfur colloid
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
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.
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.
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.
Acute Liver Failure
13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF
The ALFSG-MBT protocol is for a multicenter, open label, non-randomized study to determine the value of Breath Identification® (BreathID®) N-(4-Methoxy-13C-phenyl)acetamide (13C-Methacetin) Breath Test System in predicting the…
- Trial name
- ALFSG-MBT (NCT02786836)
- Testing
- 13C-Methacetin
- Where
- 11 sites in United States
- Volunteers
- 76 people
- Sponsor
- University of Texas Southwestern Medical Center
Liver Diseases, Liver Cancer
Breath Analysis Based Disease Biomarkers
The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.
- Conditions
- Liver Diseases, Liver Cancer, COVID19
- Trial name
- NCT04341012
- Testing
- Collection of breath sample
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Bronchiectasis
Assessment of an Exhaled Breath Test to Detect Bronchiectasis
To investigate whether the breath test is able to detect bronchiectasis using breathomics. This study was conducted with a prospective specimen collection, evaluator-blinded, case-controlled clinical study designed to evaluate…
- Trial name
- NCT05293314
- Testing
- An exhaled breath test
- Where
- China
- Volunteers
- 544 people, healthy volunteers welcome
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
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
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.
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
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.
Dilated Cardiomyopathy, Tricuspid Atresia
Methacetin Breath Test in Patients With Liver Disease Secondary to Heart Disease
The aim of this project is assess a non-invasive functional liver tests in patients with the Fontan circulation that may be used for prognostic purposes.
- Trial name
- MBT+Fontan (NCT04176458)
- Testing
- Methacetin Breath Test (MBT)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Northwestern University
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