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Poop pills may stop brain fog in liver patients

NCT ID NCT07454408

Disease control Sponsor: Air Force Military Medical University, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a fecal microbiota transplant (FMT) from healthy donors can prevent severe confusion (hepatic encephalopathy) in 40 patients who still get episodes despite standard drugs after a liver shunt procedure (TIPS). Participants receive either FMT or a placebo, and researchers track safety, recurrence rates, and quality of life. The goal is to find a new option for those not helped by current treatments.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Aged between 18 and 75 years old * Patients who have experienced esophageal-gastric variceal bleeding or recurrent refractory ascites and meet the inclusion criteria, and for whom conservative treatment has failed, are planned to undergo elective TIPS surgery * Patients with recurrent hepatic encephalopathy (HE) after transjugular intrahepatic portosystemic shunt (TIPS), despite treatment with lactulose and rifaximin (at least 2 episodes of West Haven grade ≥2 HE within 6 months under lactulose and rifaximin intervention) * Provided written informed consent from the patient Exclusion Criteria: * Malignant tumors of the liver, gastrointestinal tract or other systems * Uncontrolled severe active infection (\>grade 2) or sepsis * Spontaneous bacterial peritonitis * Complicated with severe cardiac, renal or pulmonary insufficiency * Other neuropsychiatric diseases, including dementia * Budd-Chiari syndrome * Alcohol dependence or use of psychotropic drugs (benzodiazepines, opioids, etc.) * History of gastrointestinal surgery (e.g., colectomy) within 3 months before enrollment * Pregnant or lactating subjects * Poor compliance judged by the investigator * Model for End-Stage Liver Disease (MELD) score \>17 * Tumor, immunodeficiency, or receiving immunosuppressive therapy within 3 months before enrollment * Patients who have used other prebiotics, probiotics or fecal microbiota transplantation (FMT) before enrollment

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Conditions

The condition(s) this trial relates to.

hepatic encephalopathy

As listed by the trial registrant

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

Fecal microbiota transplantation Hepatic encephalopathy TIPS

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

  • Xi'an International Medical Center Hospital

    Xi’an, Shanxi, 710100, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.