Exploring Clinical Characteristics of Liver Disease Patients Based on Digestive Metabolic Exhaled Air
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
Cirrhosis is a common digestive system disease and represents the final stage of the progression of various chronic liver diseases. During cirrhosis, the intestinal microenvironment is affected due to liver damage and increased portal venous pressure. Displacement of gut microbiota is closely related to the occurrence and development of cirrhosis. Disruption of the gut microbiota is associated with changes in the levels of nitric oxide (NO), hydrogen (H₂), methane (CH₄), and hydrogen sulfide (H₂S). Breath testing is an emerging method for assessing gut microbiota. This project aims to investigate the characteristics and prognosis of patients with chronic liver disease by detecting exhaled breath markers such as nitric oxide (NO), hydrogen (H₂), methane (CH₄), and hydrogen sulfide (H₂S), in conjunction with results from serological tests, gut microbiota analysis, and radiomics. The goal is to identify new diagnostic biomarkers and therapeutic targets, to recognize high-risk patients at an early stage, and to improve patient survival rates and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients who have received antibiotic treatment within one month; ② Patients with severe pulmonary diseases, such as chronic obstructive pulmonary disease (COPD), asthma, or lung malignancies that have not been clinically cured; ③ Patients who are unable to successfully complete the molecular breath test.
Trial population
Patients with chronic liver disease and cirrhosis hospitalized at Fudan University Affiliated Zhongshan Hospital, Shanghai Institute of Geriatric Medicine, and Minhang District Central Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 5 trial groupsGroup A: H₂ abnormality
Group B: CH₄ abnormality
Group C: H₂S abnormality
Group D: NO abnormality
Group E: Small Intestinal Bacterial Overgrowth (SIBO)
Trial outcomes
Primary outcomes
1
Gastrointestinal bleeding
Defined as a decrease in hemoglobin by 2 g/L or the presence of active bleeding, hematochezia, or other signs of bleeding.
Time frame
2 monthsSecondary outcomes
1
The occurrence of clinical events
The occurrence of events such as gastrointestinal bleeding, ascites progression, overt jaundice, and portal vein thrombosis at 6 months, 1 year, and 2 years, as well as the incidence of liver cancer, liver transplantation, or survival and death.
Time frame
6 months, 1 year, and 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov