Could a fecal transplant stop dangerous brain fog after liver surgery?
NCT ID NCT07683936
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Xi'an International Medical Center Hospital
RECRUITINGXi'an, China
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