CirrhosisNCT07455175
Observational Clinical Study on the Association Between Lactate-mediated Gut Microbiota Alterations and Disease Progression in Liver Cirrhosis.
An observational study of Cirrhosis, run by Zhujiang Hospital at 1 site in China.
Trial summary
To investigate the association between lactate-mediated alterations in the gut microbiota and disease progression in patients with liver cirrhosis; and to examine the correlations of lactate levels among serum, fecal, and tissue samples in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Oct 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Meet eligibility criteria
Who may be able to join
- 1. Healthy individuals without a history of liver disease or related underlying disorders; or patients diagnosed with liver cirrhosis and its complications based on imaging and/or liver biopsy, with a history of chronic liver disease for more than 6 months. Etiologies include chronic hepatitis B virus infection, nonalcoholic fatty liver disease, and alcoholic liver disease, among others.
- 2. Willing to participate in this study and able to provide written informed consent.
Who cannot join
- 1. A history of severe organic diseases involving the liver, gastrointestinal tract, kidneys, or other organ systems; malignant tumors; or autoimmune diseases.
- 2. Patients with acute infection or inflammatory diseases within the past 1 month.
- 3. Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
About this study
To investigate the association between lactate-mediated alterations in the gut microbiota and disease progression in patients with liver cirrhosis; and to examine the correlations of lactate levels among serum, fecal, and tissue samples in patients with liver cirrhosis.
- Conditions
- Cirrhosis
- Being tested
- observational study, no intervention
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational study, no interventionOther
observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Cirrhosis | Not described Receives: Other: observational study, no intervention | |
| Healthy control | Not described Receives: Other: observational study, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition
Measured: baseline
Lactate level
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaolong He, Study director, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455175
- Sponsor's protocol ID
- Zhujiang-xuyi-cirrhosis
- Status last verified
- Feb 2026
- First submitted
- 3 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Clinical Study on the Association Between Lactate-mediated Gut Microbiota Alterations and Disease Progression in Liver Cirrhosis.
- ClinicalTrials.gov ID
- NCT07455175
- Acronym / sponsor ID
- Zhujiang-xuyi-cirrhosis
- Conditions
- Cirrhosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 6 Mar 2026 (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.
To investigate the association between lactate-mediated alterations in the gut microbiota and disease progression in patients with liver cirrhosis; and to examine the correlations of lactate levels among serum, fecal, and tissue samples in patients with liver cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis | – | Other: observational study, no intervention |
| Healthy control | – | Other: observational study, no intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Meet eligibility criteria
Key inclusion criteria (2 listed)
- 1. Healthy individuals without a history of liver disease or related underlying disorders; or patients diagnosed with liver cirrhosis and its complications based on imaging and/or liver biopsy, with a history of chronic liver disease for more than 6 months. Etiologies include chronic hepatitis B virus infection, nonalcoholic fatty liver disease, and alcoholic liver disease, among others.
- 2. Willing to participate in this study and able to provide written informed consent.
Key exclusion criteria (3 listed)
- 1. A history of severe organic diseases involving the liver, gastrointestinal tract, kidneys, or other organ systems; malignant tumors; or autoimmune diseases.
- 2. Patients with acute infection or inflammatory diseases within the past 1 month.
- 3. Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational study, no interventionobservational study, no intervention | Other | Cirrhosis, Healthy control |
Primary outcome
Gut microbiota composition
Time frame: baseline
Lactate level
Time frame: baseline
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 6 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Xiaolong He study director
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by Zhujiang Hospital at 1 site 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 3 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: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yi Xu (+86 13364060425, xuyi2410@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota composition (time frame: baseline). The study lists 2 primary outcomes in all. 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 6 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.