CirrhosisNCT06968234
Exploring Clinical Characteristics of Liver Disease Patients Based on Digestive Metabolic Exhaled Air
An observational study of Cirrhosis and Microbiota, run by Shanghai Zhongshan Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Microbiota, Breath Tests
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic liver disease and cirrhosis hospitalized at Fudan University Affiliated Zhongshan Hospital, Shanghai Institute of Geriatric Medicine, and Minhang District Central Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Shanghai Geriatrics Medical Center
Shanghai, Shanghai Municipality, 200000
- Recruiting
Shanghai Minhang District Central Hospital
Shanghai, Shanghai Municipality, 200000
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
+86-021-65641990, ec@zs-hospital.sh.cn
About this study
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.
- Conditions
- Cirrhosis, Microbiota, Breath Tests
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| H₂ abnormality | Fasting end-expiratory H₂ ≥ 10 ppm, indicating excessive growth of hydrogen-producing bacteria in the gut. | |
| CH₄ abnormality | Fasting end-expiratory CH₄ ≥ 5 ppm, indicating excessive growth of methanogenic archaea in the gut. | |
| H₂S abnormality | Fasting end-expiratory H₂S ≥ 50 ppb, indicating excessive growth of hydrogen sulfide-producing bacteria in the gut. | |
| NO abnormality | Fasting end-expiratory NO ≥ 15 ppb, indicating the presence of low-grade intestinal inflammation or eosinophilic inflammation. | |
| Small Intestinal Bacterial Overgrowth (SIBO) | Defined as end-expiratory H₂ ≥ 10 ppm or CH₄ ≥ 5 ppm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal bleeding
Defined as a decrease in hemoglobin by 2 g/L or the presence of active bleeding, hematochezia, or other signs of bleeding.
Measured: 2 months
Secondary outcomes (1)
The occurrence of clinical events
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.
Measured: 6 months, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Mar 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiyao Chen, Ph.D., Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968234
- Sponsor's protocol ID
- B2025-179R
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Clinical Characteristics of Liver Disease Patients Based on Digestive Metabolic Exhaled Air
- ClinicalTrials.gov ID
- NCT06968234
- Acronym / sponsor ID
- B2025-179R
- Conditions
- Cirrhosis, Microbiota, Breath Tests
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| H₂ abnormality | – | –Fasting end-expiratory H₂ ≥ 10 ppm, indicating excessive growth of hydrogen-producing bacteria in the gut. |
| CH₄ abnormality | – | –Fasting end-expiratory CH₄ ≥ 5 ppm, indicating excessive growth of methanogenic archaea in the gut. |
| H₂S abnormality | – | –Fasting end-expiratory H₂S ≥ 50 ppb, indicating excessive growth of hydrogen sulfide-producing bacteria in the gut. |
| NO abnormality | – | –Fasting end-expiratory NO ≥ 15 ppb, indicating the presence of low-grade intestinal inflammation or eosinophilic inflammation. |
| Small Intestinal Bacterial Overgrowth (SIBO) | – | –Defined as end-expiratory H₂ ≥ 10 ppm or CH₄ ≥ 5 ppm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver disease and cirrhosis hospitalized at Fudan University Affiliated Zhongshan Hospital, Shanghai Institute of Geriatric Medicine, and Minhang District Central Hospital.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
The occurrence of clinical events
Time frame: 6 months, 1 year, and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shiyao Chen, Ph.D. principal investigator
Shanghai Zhongshan Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Microbiota, run by Shanghai Zhongshan Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiting Wang, Ph.D. (+86-15221919860, wang.yiting@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal bleeding (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.