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

NCT06968234 | Recruiting

• 1 other identifier: B2025-179R
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Cirrhosis; Microbiota; Breath Tests

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal bleeding

  Defined as a decrease in hemoglobin by 2 g/L or the presence of active bleeding, hematochezia, or other signs of bleeding.

  2 months

Secondary Outcomes (1)

• The occurrence of clinical events

  6 months, 1 year, and 2 years

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (3)

Shanghai Geriatrics Medical Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanghai Minhang District Central Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shiyao Chen, Ph.D.

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiting Wang, Ph.D.

CONTACT

+86-15221919860; wang.yiting@zs-hospital.sh.cn

Xiaoquan Huang, M.D.

CONTACT

+86-18801733835; huang.xiaoquan@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

CN (3)