Actively Recruiting
Exploring Clinical Characteristics of Liver Disease Patients Based on Digestive Metabolic Exhaled Air
Led by Shanghai Zhongshan Hospital · Updated on 2025-05-13
1000
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Cirrhosis is a common digestive system disease representing the final stage of various chronic liver diseases. It affects the intestinal environment due to liver damage and increased portal venous pressure. Changes in gut microbiota linked to cirrhosis can alter levels of breath markers like nitric oxide (NO), hydrogen (H₂), methane (CH₄), and hydrogen sulfide (H₂S). This study explores these breath markers alongside blood tests, gut microbiota analysis, and radiomics to find new diagnostic markers and treatment targets, aiming to identify high-risk patients early and improve survival and quality of life. Participants will undergo molecular breath tests measuring exhaled gases such as hydrogen, methane, hydrogen sulfide, and nitric oxide. Abnormal levels may indicate bacterial overgrowth or intestinal inflammation. The study includes groups based on breath marker abnormalities like excessive hydrogen-producing bacteria, methanogenic archaea, hydrogen sulfide-producing bacteria, or low-grade intestinal inflammation. These tests are performed within one week of admission. During the study, participants will be monitored for gastrointestinal bleeding over two months and tracked for clinical events at six months, one year, and two years. Researchers will analyze breath test results along with serological and microbiota data to understand disease characteristics and prognosis. This observational study is conducted by Shanghai Zhongshan Hospital and involves adults diagnosed with chronic liver disease or cirrhosis who can complete the breath test.
CONDITIONS
Brief Title
Exploring Clinical Characteristics of Liver Disease Patients Based on Digestive Metabolic Exhaled Air
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with chronic liver disease or cirrhosis through liver biopsy pathology or clinical laboratory and imaging examinations
- Undergo molecular breath testing within one week of admission
You will not qualify if you...
- Patients who have received antibiotic treatment within one month
- Patients with severe pulmonary diseases, such as chronic obstructive pulmonary disease (COPD), asthma, or lung malignancies that have not been clinically cured
- Patients who are unable to successfully complete the molecular breath test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 week of admission
Participants undergo molecular breath testing to assess digestive metabolic gases and identify abnormalities related to liver disease.
1 visit (in-person)
Duration - Up to 2 years
Participants are monitored for clinical events and gastrointestinal bleeding over time to understand disease progression.
Follow-up assessments at 2 months, 6 months, 1 year, and 2 years
Trial Site Locations
Total: 3 locations
1
Shanghai Geriatrics Medical Center
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
2
Shanghai Minhang District Central Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
3
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
Y
Yiting Wang, Ph.D.
X
Xiaoquan Huang, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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