NCT06968234 Exploring Clinical Characteristics of Liver Disease Patients Based on Digestive Metabolic Exhaled Air
| NCT ID | NCT06968234 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-03-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Shiyao Chen, Ph.D.
PRINCIPAL INVESTIGATOR
Shanghai Zhongshan Hospital
Frequently Asked Questions
Who can join the NCT06968234 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06968234 currently recruiting?
Yes, NCT06968234 is actively recruiting participants. Contact the research team at wang.yiting@zs-hospital.sh.cn for enrollment information.
Where is the NCT06968234 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China, Shanghai, China.
Who is sponsoring the NCT06968234 clinical trial?
NCT06968234 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Shiyao Chen, Ph.D. at Shanghai Zhongshan Hospital. The trial plans to enroll 1,000 participants.