Could a fecal transplant stop dangerous brain fog after liver surgery?

NCT ID NCT07683936

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Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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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 Results may not be published yet.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.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
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First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests whether fecal microbiota transplantation (FMT) — transferring stool from healthy donors into the gut — can help prevent repeated episodes of hepatic encephalopathy (a serious brain condition) in people who have had TIPS surgery for liver problems. The trial enrolls 26 adults who still experience encephalopathy despite standard treatment with rifaximin and lactulose. Participants receive FMT via a nasojejunal tube for three days, and half also get a prebiotic fiber supplement for four weeks. Researchers will track recurrence of encephalopathy, safety, and changes in gut bacteria over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fecal microbiota transplantation (FMT) with or without prebiotic fiber
What this could lead to
If successful, this approach could offer a new way to prevent repeated episodes of hepatic encephalopathy in people who have had TIPS surgery, reducing hospitalizations and improving quality of life.
What could go wrong
This is a very early, small study with only 26 participants, so results may not apply broadly. FMT carries risks of infection, gastrointestinal side effects, or worsening of encephalopathy, and the long-term safety is not yet known.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 26 people

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

Started

Jun 2026

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: * Age: 18 - 75 years old, both genders are eligible * Successful implementation of covered stent TIPS * Those who experienced recurrence of hepatic encephalopathy after TIPS surgery and still used lactulose and rifaximin (within 6 months after intervention with rifaximin and lactulose, West Haven grade ≥ 2 hepatic encephalopathy occurred at least 2 times) * Meet the conditions for receiving fecal microbiota transplantation through nasogastric tube (no severe anatomical abnormalities in the upper digestive tract; basic intestinal motility is normal; can tolerate the insertion of nasogastric tube and the subsequent infusion process) * Obtain the patient's written informed consent Exclusion Criteria: * Patients with active gastrointestinal bleeding or perforation accompanied by severe damage to the intestinal barrier due to various reasons * Patients with congenital or acquired immunodeficiency diseases, those who have received high-risk immunosuppressive or cytotoxic drug treatment within the recent 3 months, and those with severe immunosuppression (neutrophil count \< 1.5×10⁶ cells/L; CD4+ T cell count \< 2.0×10⁵ cells/L) * Patients with malignant tumors of the liver or gastrointestinal tract, patients with spontaneous bacterial peritonitis, and patients with Budd-Chiari syndrome * Patients with severe heart, kidney, or lung dysfunction (NYHA III-IV grade or unstable heart failure; eGFR \< 30 ml/min/1.73m² or requiring dialysis; respiratory failure or requiring long-term oxygen therapy) * Unstable vital signs (body temperature, heart rate, blood pressure, breathing) * History of gastrointestinal surgery within the past 3 months, such as colon resection * Patients planning to undergo liver transplantation within 6 months * Patients who have undergone FMT within the past 3 months * Alcohol dependence or use of psychotropic drugs (benzodiazepines, opioids, etc.) * Other neurological and psychiatric disorders, including dementia, Parkinson's disease, and post-stroke sequelae * Pregnant or lactating subjects * Subjects considered to have poor compliance by the investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Xi'an International Medical Center Hospital

    RECRUITING

    Xi'an, China

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