Cirrhoses, LiverNCT07150195
Study on Proteomic and Microbiome Changes in Patients With Hepatic Encephalopathy (HE)
An observational study of Cirrhoses, Liver and Hepatic Encephalopathy (HE), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The objective of this observational study is to compare the differences in proteomics and gut microbiome between the liver cirrhosis group without hepatic encephalopathy and the hepatic encephalopathy group through proteomics and microbiome analysis, screen out the characteristic proteomics and microbiome of patients… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cirrhoses, Liver, Hepatic Encephalopathy (HE)
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Sep 2025to Dec 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study Population: A hospital-based cohort of adult patients (aged 18-85 years) with a confirmed diagnosis of liver cirrhosis, specifically recruited to form two distinct study groups based on the presence or absence of hepatic encephalopathy (HE) and blood ammonia levels. Sampling Method: Non-Probability Sample. Participants will be consecutively recruited from inpatient units. A purposive sampling strategy will be employed to ensure the successful enrollment of a sufficient number of participants in the Hepatic Encephalopathy (HE) group.
Who may be able to join
- For the NHE (No Hepatic Encephalopathy) Group:
- Aged between 18 and 85 years, inclusive.
- Diagnosis of liver cirrhosis.
- Normal blood ammonia level.
- West-Haven Criteria grade 0 for Hepatic Encephalopathy.
- Normal neurological signs.
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- Normal neuropsychological test results.
- Willing to participate and provides written informed consent.
- For the CHE (Covert Hepatic Encephalopathy) Group:
- Aged between 18 and 85 years, inclusive.
- Diagnosis of liver cirrhosis.
- Elevated blood ammonia level.
- Diagnosis of Covert Hepatic Encephalopathy (West-Haven Criteria grade 0 or I).
- Grade 0: No personality or behavioral changes but abnormal neuropsychological tests.
- Grade I: Mild cognitive impairment, lack of awareness, euphoria or anxiety, shortened attention span, or impaired performance of addition/subtraction.
- Neurological signs are normal or mild asterixis (flapping tremor) may be elicited.
- Neuropsychological tests are abnormal.
- Willing to participate and provides written informed consent.
Who cannot join
- Diagnosis of any malignant tumor.
- History of treatment for any malignant tumor.
- Presence of severe concomitant cardiac, pulmonary, cerebral, or renal diseases, or severe diabetic complications.
- Use of antibiotics, prebiotics, probiotics, or proton pump inhibitors within the three months prior to enrollment.
- Pregnancy, lactation, or puerperium.
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
Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
About this study
The objective of this observational study is to compare the differences in proteomics and gut microbiome between the liver cirrhosis group without hepatic encephalopathy and the hepatic encephalopathy group through proteomics and microbiome analysis, screen out the characteristic proteomics and microbiome of patients with hepatic encephalopathy, guide clinical diagnosis and treatment, and conduct in-depth research on the pathogenesis of hepatic encephalopathy. The main questions it aims to answer are:
Are there any differences in serum proteomes between patients with liver cirrhosis without hepatic encephalopathy and those with hepatic encephalopathy? If so, what are the main protein differences? There are differences in the fecal microbiome between patients with liver cirrhosis without hepatic encephalopathy and those with hepatic encephalopathy? If so, what are the main microbial differences?
This study will screen for the differences in proteomes and gut microbiomes between patients with liver cirrhosis without hepatic encephalopathy and those with hepatic encephalopathy, and identify the characteristic proteomes and microbiomes of patients with hepatic encephalopathy to guide clinical diagnosis and treatment.
- Conditions
- Cirrhoses, Liver, Hepatic Encephalopathy (HE)
- Medical subject headings
- Hepatic Encephalopathy
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 |
|---|---|---|
| Liver cirrhosis non-hepatic encephalopathy group (NHE group) | Patients with liver cirrhosis aged ≥18 years, with normal blood ammonia; West-Haven classification 0, normal neurological signs, and normal neuropsychological tests; The patient agreed to participate and signed the informed consent form. | |
| Liver cirrhosis hepatic encephalopathy group (HE group） | Patients with liver cirrhosis aged 18 years or older, with elevated blood ammonia; Subclinical hepatic encephalopathy and West-Haven classification of grades 0, 1 to 4 HE, presenting with mental abnormalities such as personality and behavioral changes, and neurological abnormalities such as coma; Neurological signs are normal/flapping tremors can be elicited/positive neurological signs such as ankle clonus, and neuropsychological tests are abnormal; The patient/legal guardian agrees to participate and signs the informed consent form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological and proteomic measurements
- Microbiome Alpha Diversity (Shannon Index) Variable Name: Shannon Index Unit of Measure: Unitless (Shannon Index is a dimensionless quantity) Description: Alpha diversity assessed from 16S rRNA sequencing data using the Shannon Index, analyzed via QIIME.
- Relative Abundance of Specific Bacterial Taxa Variable Name: Relative Abundance Unit of Measure: % Description: The relative abundance of specific bacterial taxa, derived from 16S rRNA sequencing data analyzed using QIIME.
- Proteomic Abundance of Specific Proteins Variable Name: Protein Abundance Unit of Measure: Arbitrary Intensity Units Description: Abundance of specific proteins measured by mass spectrometry-based proteomic analysis.
Measured: September 2025 - June 2026
Secondary outcomes (1)
1.Demographic and Clinical Characteristics Assessment using Data Collection Forms 2.Cognitive Function Assessment using Mini-Mental State Examination (MMSE) 3.Laboratory Blood Parameters Measured by Standard Clinical Laboratory Assays
- Participant Characteristics Sex (n) Height (m) Weight (kg) Body Mass Index, BMI (kg/m²) Disease Duration (months) Description: Data collected via questionnaire, medical record review, and physical measurement. BMI was calculated from height and weight.
II. Cognitive Function Mini-Mental State Examination, MMSE Score (points, 0-30)
III. Laboratory Parameters - Hematology Hemoglobin (g/dL) White Blood Cell Count (×10⁹/L) Platelet Count (×10⁹/L)
IV. Laboratory Parameters - Coagulation Prothrombin Time (s)
- Laboratory Parameters - Liver Function and Metabolism Blood Ammonia (μmol/L) Serum Albumin (g/dL) Alanine Aminotransferase, ALT (U/L) Aspartate Aminotransferase, AST (U/L)
Measured: September 2025 - June 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cirrhoses, LiverStudies 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
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenfang Cheng, Study director, Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150195
- Sponsor's protocol ID
- Wenfang Chen
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are currently undecided regarding sharing of Individual Participant Data (IPD). The primary reason for this uncertainty is to ensure full compliance with all regulatory obligations and to uphold the confidentiality commitments made to the study participants during the informed consent process. Therefore, sharing IPD would require further review and approval by the relevant Institutional Review Board (IRB)/Ethics Committee, and in some cases, may necessitate re-consenting participants, which is not always feasible. The investigators acknowledge the importance of data sharing for scientific progress. A final decision will be made following the completion of the study and publication of the primary results. The investigators will formally consult with the IRB/Ethics Committee and the data protection officers to determine if and how the data can be shared in a manner that is fully compliant with Chinese regulations and international standards for data privacy.
Publications
Munk Lauridsen M, Jonasson E, Bajaj JS. Microbial Approaches to Treat and Prevent Hepatic Encephalopathy. Gastroenterol Clin North Am. 2025 Jun;54(2):429-451. doi: 10.1016/j.gtc.2024.12.006. Epub 2025 Jan 23.
PubMed 40348497Engelmann C. Rethinking hepatic encephalopathy: Gut microbes, neurotoxins and the therapeutic horizon. J Hepatol. 2025 Aug;83(2):601-603. doi: 10.1016/j.jhep.2025.04.036. Epub 2025 May 27. No abstract available.
PubMed 40436647Li S, Xu Z, Diao H, Zhou A, Tu D, Wang S, Feng Y, Feng X, Lai Y, Yang S, Tang B. Gut microbiome alterations and hepatic encephalopathy post-TIPS in liver cirrhosis patients. J Transl Med. 2025 Jul 4;23(1):745. doi: 10.1186/s12967-025-06774-y.
PubMed 40615853Mancini A, Campagna F, Amodio P, Tuohy KM. Gut : liver : brain axis: the microbial challenge in the hepatic encephalopathy. Food Funct. 2018 Mar 1;9(3):1373-1388. doi: 10.1039/c7fo01528c. Epub 2018 Feb 27.
PubMed 29485654Stengel S, Stallmach A, Richter K, Landrock A, Hampe J, Bruns T. Serum metabolic signatures in patients with overt hepatic encephalopathy. J Hepatol. 2017 Nov;67(5):1114-1115. doi: 10.1016/j.jhep.2017.06.030. Epub 2017 Jul 6. No abstract available.
PubMed 28690175
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Proteomic and Microbiome Changes in Patients With Hepatic Encephalopathy (HE)
- ClinicalTrials.gov ID
- NCT07150195
- Acronym / sponsor ID
- Wenfang Chen
- Conditions
- Cirrhoses, Liver, Hepatic Encephalopathy (HE)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Sep 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.
The objective of this observational study is to compare the differences in proteomics and gut microbiome between the liver cirrhosis group without hepatic encephalopathy and the hepatic encephalopathy group through proteomics and microbiome analysis, screen out the characteristic proteomics and microbiome of patients with hepatic encephalopathy, guide clinical diagnosis and treatment, and conduct in-depth research on the pathogenesis of hepatic encephalopathy. The main questions it aims to answer are:
Are there any differences in serum proteomes between patients with liver cirrhosis without hepatic encephalopathy and those with hepatic encephalopathy? If so, what are the main protein differences? There are differences in the fecal microbiome between patients with liver cirrhosis without hepatic encephalopathy and those with hepatic encephalopathy? If so, what are the main microbial differences?
This study will screen for the differences in proteomes and gut microbiomes between patients with liver cirrhosis without hepatic encephalopathy and those with hepatic encephalopathy, and identify the characteristic proteomes and microbiomes of patients with hepatic encephalopathy to guide clinical diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver cirrhosis non-hepatic encephalopathy group (NHE group) | – | –Patients with liver cirrhosis aged ≥18 years, with normal blood ammonia; West-Haven classification 0, normal neurological signs, and normal neuropsychological tests; The patient agreed to participate and signed the informed consent form. |
| Liver cirrhosis hepatic encephalopathy group (HE group） | – | –Patients with liver cirrhosis aged 18 years or older, with elevated blood ammonia; Subclinical hepatic encephalopathy and West-Haven classification of grades 0, 1 to 4 HE, presenting with mental abnormalities such as personality and behavioral changes, and neurological abnormalities such as coma; Neurological signs are normal/flapping tremors can be elicited/positive neurological signs such as ankle clonus, and neuropsychological tests are abnormal; The patient/legal guardian agrees to participate and signs the informed consent form. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population: A hospital-based cohort of adult patients (aged 18-85 years) with a confirmed diagnosis of liver cirrhosis, specifically recruited to form two distinct study groups based on the presence or absence of hepatic encephalopathy (HE) and blood ammonia levels. Sampling Method: Non-Probability Sample. Participants will be consecutively recruited from inpatient units. A purposive sampling strategy will be employed to ensure the successful enrollment of a sufficient number of participants in the Hepatic Encephalopathy (HE) group.
Key inclusion criteria (18 listed)
- Aged between 18 and 85 years, inclusive.
- Diagnosis of liver cirrhosis.
- Normal blood ammonia level.
- West-Haven Criteria grade 0 for Hepatic Encephalopathy.
- Normal neurological signs.
Key exclusion criteria (5 listed)
- Diagnosis of any malignant tumor.
- History of treatment for any malignant tumor.
- Presence of severe concomitant cardiac, pulmonary, cerebral, or renal diseases, or severe diabetic complications.
- Use of antibiotics, prebiotics, probiotics, or proton pump inhibitors within the three months prior to enrollment.
- Pregnancy, lactation, or puerperium.
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
Microbiological and proteomic measurements
Time frame: September 2025 - June 2026
1. Microbiome Alpha Diversity (Shannon Index) Variable Name: Shannon Index Unit of Measure: Unitless (Shannon Index is a dimensionless quantity) Description: Alpha diversity assessed from 16S rRNA sequencing data using the Shannon Index, analyzed via QIIME. 2. Relative Abundance of Specific Bacterial Taxa Variable Name: Relative Abundance Unit of Measure: % Description: The relative abundance of specific bacterial taxa, derived from 16S rRNA sequencing data analyzed using QIIME. 3. Proteomic Abundance of Specific Proteins Variable Name: Protein Abundance Unit of Measure: Arbitrary Intensity Units Description: Abundance of specific proteins measured by mass spectrometry-based proteomic analysis.
1 secondary outcome
1.Demographic and Clinical Characteristics Assessment using Data Collection Forms 2.Cognitive Function Assessment using Mini-Mental State Examination (MMSE) 3.Laboratory Blood Parameters Measured by Standard Clinical Laboratory Assays
Time frame: September 2025 - June 2026
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 25 Sep 2025.
- Results publication: PubMed 40348497Munk Lauridsen M, Jonasson E, Bajaj JS. Microbial Approaches to Treat and Prevent Hepatic Encephalopathy. Gastroenterol Clin North Am. 2025 Jun;54(2):429-451. doi: 10.1016/j.gtc.2024.12.006. Epub 2025 Jan 23.
- Results publication: PubMed 40436647Engelmann C. Rethinking hepatic encephalopathy: Gut microbes, neurotoxins and the therapeutic horizon. J Hepatol. 2025 Aug;83(2):601-603. doi: 10.1016/j.jhep.2025.04.036. Epub 2025 May 27. No abstract available.
- Results publication: PubMed 40615853Li S, Xu Z, Diao H, Zhou A, Tu D, Wang S, Feng Y, Feng X, Lai Y, Yang S, Tang B. Gut microbiome alterations and hepatic encephalopathy post-TIPS in liver cirrhosis patients. J Transl Med. 2025 Jul 4;23(1):745. doi: 10.1186/s12967-025-06774-y.
- Results publication: PubMed 29485654Mancini A, Campagna F, Amodio P, Tuohy KM. Gut : liver : brain axis: the microbial challenge in the hepatic encephalopathy. Food Funct. 2018 Mar 1;9(3):1373-1388. doi: 10.1039/c7fo01528c. Epub 2018 Feb 27.
- Results publication: PubMed 28690175Stengel S, Stallmach A, Richter K, Landrock A, Hampe J, Bruns T. Serum metabolic signatures in patients with overt hepatic encephalopathy. J Hepatol. 2017 Nov;67(5):1114-1115. doi: 10.1016/j.jhep.2017.06.030. Epub 2017 Jul 6. No abstract available.
- Individual participant dataSharing planned: Undecided. The investigators are currently undecided regarding sharing of Individual Participant Data (IPD). The primary reason for this uncertainty is to ensure full compliance with all regulatory obligations and to uphold the confidentiality commitments made to the study participants during the informed consent process. Therefore, sharing IPD would require further review and approval by the relevant Institutional Review Board (IRB)/Ethics Committee, and in some cases, may necessitate re-consenting participants, which is not always feasible. The investigators acknowledge the importance of data sharing for scientific progress. A final decision will be made following the completion of the study and publication of the primary results. The investigators will formally consult with the IRB/Ethics Committee and the data protection officers to determine if and how the data can be shared in a manner that is fully compliant with Chinese regulations and international standards for data privacy.
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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.
Wenfang Cheng study director
Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical University
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 Cirrhoses, Liver and Hepatic Encephalopathy (HE), run by The First Affiliated Hospital with Nanjing Medical University 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 18 inclusion and 5 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 25 Sep 2025. 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 Wenfang Cheng ((+86)13062589271, chengwenfang@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological and proteomic measurements (time frame: September 2025 - June 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07150195, which also lists 5 linked publications.
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 25 Sep 2025.