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Scientists hunt for clues in gut and blood to spot hidden brain trouble in liver patients

NCT ID NCT07150195

Knowledge-focused Sponsor: The First Affiliated Hospital with Nanjing Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at differences in proteins and gut bacteria between liver cirrhosis patients with and without hepatic encephalopathy (a brain complication). Researchers will analyze blood and stool samples from 32 adults to find unique patterns that could help diagnose and understand the disease better. Participants are not given any treatment; the goal is to gather knowledge.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For the NHE (No Hepatic Encephalopathy) Group: 1. Aged between 18 and 85 years, inclusive. 2. Diagnosis of liver cirrhosis. 3. Normal blood ammonia level. 4. West-Haven Criteria grade 0 for Hepatic Encephalopathy. 5. Normal neurological signs. 6. Normal neuropsychological test results. 7. Willing to participate and provides written informed consent. For the CHE (Covert Hepatic Encephalopathy) Group: 1. Aged between 18 and 85 years, inclusive. 2. Diagnosis of liver cirrhosis. 3. Elevated blood ammonia level. 4. 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. 5. Neurological signs are normal or mild asterixis (flapping tremor) may be elicited. 6. Neuropsychological tests are abnormal. 7. Willing to participate and provides written informed consent. Exclusion Criteria: 1. Diagnosis of any malignant tumor. 2. History of treatment for any malignant tumor. 3. Presence of severe concomitant cardiac, pulmonary, cerebral, or renal diseases, or severe diabetic complications. 4. Use of antibiotics, prebiotics, probiotics, or proton pump inhibitors within the three months prior to enrollment. 5. Pregnancy, lactation, or puerperium.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver hepatic encephalopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhoses, liver Hepatic encephalopathy (HE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Gastroenterology, the First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, China

More trials for these conditions

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