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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06968234
Enrollment
1000
Registered
2025-05-13
Start date
2025-03-01
Completion date
2028-12-31
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breath Tests, Cirrhosis, Microbiota

Brief summary

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.

Interventions

None listed

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gastrointestinal bleeding2 monthsDefined as a decrease in hemoglobin by 2 g/L or the presence of active bleeding, hematochezia, or other signs of bleeding.

Secondary

MeasureTime frameDescription
The occurrence of clinical events6 months, 1 year, and 2 yearsThe 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.

Countries

China

Contacts

Primary ContactYiting Wang, Ph.D.
wang.yiting@zs-hospital.sh.cn+86-15221919860
Backup ContactXiaoquan Huang, M.D.
huang.xiaoquan@zs-hospital.sh.cn+86-18801733835

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026