Examining breath markers in liver disease patients
Exploring Clinical Characteristics of Liver Disease Patients Based on Digestive Metabolic Exhaled Air
Shanghai Zhongshan Hospital · NCT06968234
This study is trying to see if certain breath markers can help identify and understand the progression of liver disease in patients, especially those with cirrhosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital (other) |
| Locations | 3 sites (Shanghai, Shanghai Municipality and 2 other locations) |
| Trial ID | NCT06968234 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the characteristics and prognosis of patients with chronic liver disease, particularly cirrhosis, by analyzing exhaled breath markers such as nitric oxide, hydrogen, methane, and hydrogen sulfide. The study aims to correlate these breath markers with serological tests, gut microbiota analysis, and radiomics to identify new diagnostic biomarkers and therapeutic targets. By understanding the relationship between gut microbiota disruption and liver disease progression, the research seeks to recognize high-risk patients and improve clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with chronic liver disease or cirrhosis who can undergo molecular breath testing shortly after admission.
Not a fit: Patients who have recently received antibiotic treatment or have severe pulmonary diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of new diagnostic tools and therapeutic strategies for patients with chronic liver disease.
How similar studies have performed: While breath testing for gut microbiota assessment is an emerging field, this specific approach to studying liver disease is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality and 2 other locations
- Shanghai Geriatrics Medical Center — Shanghai, Shanghai Municipality, China (RECRUITING)
- Shanghai Minhang District Central Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
- Zhongshan Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Shiyao Chen, Ph.D. — Shanghai Zhongshan Hospital
- Study coordinator: Yiting Wang, Ph.D.
- Email: wang.yiting@zs-hospital.sh.cn
- Phone: +86-15221919860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cirrhosis, Microbiota, Breath Tests