Evaluation of the Outcome of Fecal Microbiota Transplantation

March 5, 2026 updated by: Guohong Han, Air Force Military Medical University, China

A Clinical Randomized Controlled Study on the Prevention and Treatment of Drug-refractory Hepatic Encephalopathy After TIPS With Fecal Microbiota Transplantation

This study is a randomized, placebo-controlled, exploratory phase II clinical trial led by Professor Han Gyeong-ho from the Digestive Disease Hospital of Xi'an International Medical Center. The study enrolled 40 patients who had experienced recurrence of hepatic encephalopathy despite treatment with rifaximin and lactulose. These patients were randomly divided 1:1 into the experimental group and the control group. After obtaining informed consent from the patients, fecal microbiota transplantation or placebo control was performed. The fecal microbiota was sourced from the feces of healthy individuals who had a rich composition of the Muribaculaceae, Ruminococcaceae, and Bifidobacteriaceae families and did not contain pathogenic bacteria. The safety and efficacy of the treatment were followed up, and blood and fecal samples were collected for sequencing analysis. The aim was to provide new solutions for patients with hepatic encephalopathy who did not respond to the treatment with rifaximin and lactulose after TIPS surgery; and to explore the impact of microbiota changes and translocation on the recurrence of hepatic encephalopathy after TIPS surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Detailed Description

This study is a single-center, randomized, placebo-controlled, exploratory phase II clinical trial. A total of 40 patients aged 18-75 years who had drug-refractory hepatic encephalopathy after transjugular intrahepatic portosystemic shunt surgery and experienced at least 2 West Haven grade ≥2 hepatic encephalopathy episodes within 6 months of treatment with lactulose and rifaximin were planned to be enrolled: These patients were randomly assigned in a 1:1 ratio to the fecal microbiota transplantation group and the placebo group. Both groups received basic standard treatment: 1200mg/day of rifaximin + 25ml/once of lactulose, twice/day; The FMT group was additionally infused with fecal suspension (100mL/once, twice/day, for 3 consecutive days) through the nasal jejunostomy tube combined with oral enteric-coated freeze-dried fecal capsules (7 capsules each time, for 1 week), while the placebo group was given the same volume of placebo solution and placebo capsules, with the same frequency and duration as the FMT group. All subjects were followed up at 15 days, 1 month, 3 months, and 6 months after transplantation. The primary outcomes were the safety (adverse events, severe adverse events, FMT-related adverse events) and efficacy (hepatic encephalopathy recurrence rate, time to first recurrence, West Haven classification) of FMT; The secondary outcomes were changes in intestinal flora colonization and diversity, liver function, blood ammonia levels, and health-related quality of life (CLDQ scale). Fecal and blood samples were collected at each follow-up time point for multi-omics detection and analysis. Statistical analysis of the trial data was performed using Kaplan-Meier method, Log-rank test, and Cox proportional hazards regression model.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanxi
      • Xi’an, Shanxi, China, 710100
        • Xi'an International Medical Center Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fecal Microbiota Transplantation Group
All the subjects in this arm continued to receive standard medical treatment for hepatic encephalopathy: rifaximin 0.2g per tablet, 2 tablets per dose, 3 times a day, with a total daily dose of 1200mg; lactulose oral solution 25ml per dose, 2 times a day, with the dosage adjusted as needed according to clinical requirements. On the basis of the standard treatment, the subjects received intranasal jejunal tube infusion of fecal suspension (100mL per dose, 2 times a day, for 3 consecutive days), followed by oral enteric-coated freeze-dried fecal capsules (7 capsules per day, for 1 week). The fecal preparation was prepared under sterile conditions. The donor feces used were all subjected to strict screening for infectious diseases and pathogenicity and were rich in Clostridium mucosum, Rumenoccus, and Bifidobacterium.
Biological: Fecal Microbiota Transplantation
Fecal microbiota transplantation is used to reconstruct gut microbiota structure, regulate intestinal microecological homeostasis, improve intestinal barrier function, reduce systemic endotoxin load and inflammatory level, for the prevention and treatment of refractory hepatic encephalopathy after TIPS. The preparation is made from stool of qualified screened donors, processed under sterile conditions.
Other Names:
  • FMT
Drug: Rifaximin、Lactulose
Rifaximin is a non-absorbable oral rifamycin antibiotic, used as standard medical therapy for hepatic encephalopathy, to reduce intestinal urease-producing bacteria and intestinal ammonia production.Lactulose is a synthetic disaccharide laxative, used as first-line standard medical therapy for hepatic encephalopathy, to acidify the intestinal lumen, reduce ammonia production and promote ammonia excretion.
Placebo Comparator: Placebo Control Group
All subjects in this arm will receive the exact same standard medical therapy as the FMT group: rifaximin 0.2g tablets, 2 tablets each time, 3 times daily (total 1200mg per day); lactulose oral solution 25ml each time, twice daily, with dose adjusted according to clinical needs. On top of standard therapy, subjects will receive isovolumetric placebo solution via nasojejunal tube infusion (same frequency and duration as the FMT group), followed by matched oral placebo capsules (same dosage, frequency and duration as the FMT group). Placebo preparations are identical to FMT preparations in appearance, dosage form and administration route.
Drug: Rifaximin、Lactulose
Rifaximin is a non-absorbable oral rifamycin antibiotic, used as standard medical therapy for hepatic encephalopathy, to reduce intestinal urease-producing bacteria and intestinal ammonia production.Lactulose is a synthetic disaccharide laxative, used as first-line standard medical therapy for hepatic encephalopathy, to acidify the intestinal lumen, reduce ammonia production and promote ammonia excretion.
Other: FMT Matched Placebo
Placebo preparation is identical to fecal microbiota transplantation preparation in appearance, dosage form, administration route and frequency, with no active biological or therapeutic components, used for the control arm of this randomized controlled trial.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of treatment-related adverse events (AEs) and serious adverse events (SAEs)
Time Frame: From the date of randomization to the end of 6-month follow-up after intervention
Record the number, incidence, severity (graded by NCI-CTC v3.0 criteria), correlation with trial intervention, and outcome of all AEs, FMT-related AEs and SAEs in subjects from randomization to the end of follow-up. Key monitoring includes gastrointestinal reactions, infection, exacerbation of hepatic encephalopathy and other intervention-related adverse events.
From the date of randomization to the end of 6-month follow-up after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The recurrence rate of hepatic encephalopathy fecal microbiota transplantation intervention
Time Frame: From the date of randomization to the end of 6-month follow-up after intervention
The ratio of the number of patients with recurrent hepatic encephalopathy to the total number of patients in each group
From the date of randomization to the end of 6-month follow-up after intervention
The changes in health-related quality of life after fecal microbiota transplantation intervention
Time Frame: Baseline, 1 month after intervention, 3 months after intervention, 6 months after intervention
The health-related quality of life was evaluated through the Chronic Liver Disease Questionnaire (CLDQ), with the lowest score being 1 and the highest score being 7. The higher the score, the better the health-related quality of life.
Baseline, 1 month after intervention, 3 months after intervention, 6 months after intervention
The colonization status of the intestinal microbiota
Time Frame: Baseline, 15 days after intervention, 1 month after intervention, 3 months after intervention, 6 months after intervention
The survival rate (%) of the donor microbiota in the patient's intestinal tract
Baseline, 15 days after intervention, 1 month after intervention, 3 months after intervention, 6 months after intervention
Changes in the α diversity of the intestinal microbiota
Time Frame: Baseline, 15 days after intervention, 1 month after intervention, 3 months after intervention, 6 months after intervention
Using metagenomic sequencing technology, the α diversity of the intestinal microbiota (Shannon index, Simpson index) was evaluated.
Baseline, 15 days after intervention, 1 month after intervention, 3 months after intervention, 6 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Air Force Military Medical University, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Guohong HAN, Professor, Xi'an International Medical Center Hospital
  • Principal Investigator: Guohong HAN, Professor, Xi'an International Medical Center Hospital
  • Study Director: Mingtao ZHAO, Xi'an Jiaotong University
  • Study Director: Menghao LI, Xi'an International Medical Center Hospital
  • Study Director: Heng ZENG, Xi'an International Medical Center Hospital
  • Study Director: Xing WANG, Xi'an International Medical Center Hospital
  • Study Director: Gui ZHANG, Xi'an International Medical Center Hospital
  • Study Director: Zhanxin YIN, Xi'an International Medical Center Hospital
  • Study Director: Ruijun LI, Xi'an International Medical Center Hospital
  • Study Director: Wei BAI, Xi'an International Medical Center Hospital
  • Study Director: Dongdong XIA, Xi'an International Medical Center Hospital
  • Study Director: Na ZHANG, Xi'an International Medical Center Hospital
  • Study Director: Zhengyu WANG, Xi'an International Medical Center Hospital
  • Study Director: Bohan LUO, Xi'an International Medical Center Hospital
  • Study Director: Feifei WU, Xi'an International Medical Center Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TIPS-HE-FMT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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