Exploring Clinical Characteristics of Liver Disease Patients Based on Digestive Metabolic Exhaled Air

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.

Recruiting

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Key information

Conditions

Cirrhosis Breath Tests Fibrosis Microbiota Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Geriatrics Medical Center, Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

① Patients diagnosed with chronic liver disease or cirrhosis through liver biopsy pathology or clinical laboratory and imaging examinations;

② Undergo molecular breath testing within one week of admission.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Gastrointestinal bleeding

Time frame: 2 months

Defined as a decrease in hemoglobin by 2 g/L or the presence of active bleeding, hematochezia, or other signs of bleeding.

Secondary outcomes

The occurrence of clinical events

Time frame: 6 months, 1 year, and 2 years

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoquan Huang, M.D.

CONTACT

[email protected]

+86-18801733835

Yiting Wang, Ph.D.

CONTACT

[email protected]

+86-15221919860

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: May 13, 2025
Registry last updated: May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed