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

NCT ID: NCT06968234

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cirrhosis Microbiota Breath Tests

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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H₂ abnormality

Fasting end-expiratory H₂ ≥ 10 ppm, indicating excessive growth of hydrogen-producing bacteria in the gut.

No interventions assigned to this group

CH₄ abnormality

Fasting end-expiratory CH₄ ≥ 5 ppm, indicating excessive growth of methanogenic archaea in the gut.

No interventions assigned to this group

H₂S abnormality

Fasting end-expiratory H₂S ≥ 50 ppb, indicating excessive growth of hydrogen sulfide-producing bacteria in the gut.

No interventions assigned to this group

NO abnormality

Fasting end-expiratory NO ≥ 15 ppb, indicating the presence of low-grade intestinal inflammation or eosinophilic inflammation.

No interventions assigned to this group

Small Intestinal Bacterial Overgrowth (SIBO)

Defined as end-expiratory H₂ ≥ 10 ppm or CH₄ ≥ 5 ppm.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shiyao Chen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

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Shanghai Geriatrics Medical Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Minhang District Central Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yiting Wang, Ph.D.

Role: CONTACT

+86-15221919860

Xiaoquan Huang, M.D.

Role: CONTACT

+86-18801733835

Facility Contacts

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Role: primary

+86-021-65641990

Other Identifiers

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B2025-179R

Identifier Type: -

Identifier Source: org_study_id

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