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Hepatic EncephalopathyPhase 1/2NCT07454408

Evaluation of the Outcome of Fecal Microbiota Transplantation

A Phase 1/2 study testing Fecal Microbiota Transplantation and Rifaximin、Lactulose in people with Hepatic Encephalopathy and Fecal Microbiota Transplantation, run by Air Force Military Medical University, China at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
Fecal Microbiota Transplantation and Rifaximin、Lactulose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteChina
Study dates
7 Mar 2026to 30 Jun 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guohong HAN, Professor contact

13991969930

13991969930@126.com

China1 site

  • Xi'an International Medical Center Hospital

    Xi’an, Shanxi, 710100

    Guohong HAN, MD, PhD, 86-29-84771537, 13991969930@126.com

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Fecal Microbiota Transplantation, FMT Matched Placebo, Rifaximin、Lactulose
Keywords
Hepatic Encephalopathy, Fecal Microbiota Transplantation, TIPS, FMT
Medical subject headings
Hepatic Encephalopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal Microbiota TransplantationBiological

    Also called FMT

    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.

  • FMT Matched PlaceboOther

    Also called 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.

  • Rifaximin、LactuloseDrug

    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.

Study groups in NCT07454408
Study groupRoleWhat they receive
Fecal Microbiota Transplantation GroupExperimentalAll 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.
Receives: Biological: Fecal Microbiota Transplantation; Drug: Rifaximin、Lactulose
Placebo Control GroupPlacebo comparatorAll 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.
Receives: Other: FMT Matched Placebo; Drug: Rifaximin、Lactulose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of treatment-related adverse events (AEs) and serious adverse events (SAEs)

    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.

    Measured: From the date of randomization to the end of 6-month follow-up after intervention

Secondary outcomes (4)

  1. The recurrence rate of hepatic encephalopathy fecal microbiota transplantation intervention

    The ratio of the number of patients with recurrent hepatic encephalopathy to the total number of patients in each group

    Measured: From the date of randomization to the end of 6-month follow-up after intervention

  2. The changes in health-related quality of life after fecal microbiota transplantation 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.

    Measured: Baseline, 1 month after intervention, 3 months after intervention, 6 months after intervention

  3. The colonization status of the intestinal microbiota

    The survival rate (%) of the donor microbiota in the patient's intestinal tract

    Measured: Baseline, 15 days after intervention, 1 month after intervention, 3 months after intervention, 6 months after intervention

  4. Changes in the α diversity of the intestinal microbiota

    Using metagenomic sequencing technology, the α diversity of the intestinal microbiota (Shannon index, Simpson index) was evaluated.

    Measured: Baseline, 15 days after intervention, 1 month after intervention, 3 months after intervention, 6 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study start7 Mar 2026 (estimated)
  3. Primary completion6 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a single-center, randomized, placebo-controlled, exploratory phase II clinical trial. A total of 40 eligible patients aged 18-75 years with drug-refractory hepatic encephalopathy (HE) after TIPS (≥2 episodes of West Haven ≥2 grade HE within 6 months despite lactulose and rifaximin treatment) will be enrolled. Subjects will be 1:1 randomly assigned to the FMT group or placebo group. Both groups will receive standard HE therapy (rifaximin + lactulose). The FMT group will receive FMT via nasojejunal infusion plus oral capsules, while the control group will receive matched placebo with the same administration regimen. All subjects will be followed up for 6 months to evaluate the safety and efficacy of FMT.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07454408
Sponsor's protocol ID
TIPS-HE-FMT
Status last verified
Mar 2026
First submitted
2 Mar 2026
Last updated
6 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bajaj JS, Fagan A, Gavis EA, Sterling RK, Gallagher ML, Lee H, Matherly SC, Siddiqui MS, Bartels A, Mousel T, Davis BC, Puri P, Fuchs M, Moutsoglou DM, Thacker LR, Sikaroodi M, Gillevet PM, Khoruts A. Microbiota transplant for hepatic encephalopathy in cirrhosis: The THEMATIC trial. J Hepatol. 2025 Jul;83(1):81-91. doi: 10.1016/j.jhep.2024.12.047. Epub 2025 Jan 10.

    PubMed 39800192

  • Bajaj JS, Kassam Z, Fagan A, Gavis EA, Liu E, Cox IJ, Kheradman R, Heuman D, Wang J, Gurry T, Williams R, Sikaroodi M, Fuchs M, Alm E, John B, Thacker LR, Riva A, Smith M, Taylor-Robinson SD, Gillevet PM. Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial. Hepatology. 2017 Dec;66(6):1727-1738. doi: 10.1002/hep.29306. Epub 2017 Oct 30.

    PubMed 28586116

  • Bajaj JS, Salzman NH, Acharya C, Sterling RK, White MB, Gavis EA, Fagan A, Hayward M, Holtz ML, Matherly S, Lee H, Osman M, Siddiqui MS, Fuchs M, Puri P, Sikaroodi M, Gillevet PM. Fecal Microbial Transplant Capsules Are Safe in Hepatic Encephalopathy: A Phase 1, Randomized, Placebo-Controlled Trial. Hepatology. 2019 Nov;70(5):1690-1703. doi: 10.1002/hep.30690. Epub 2019 Jun 18.

    PubMed 31038755

  • Porcari S, Ciccarese C, Heidrich V, Rondinella D, Quaranta G, Severino A, Arduini D, Buti S, Fornarini G, Primi F, Stumbo L, Giannarelli D, Giudice GC, Damassi A, Giron Berrios JR, Puncochar M, Barbazuk TB, Piccinno G, Pinto F, Armanini F, Asnicar F, Schinzari G, Derosa L, Kroemer G, Sanguinetti M, Masucci L, Gasbarrini A, Tortora G, Cammarota G, Zitvogel L, Segata N, Iacovelli R, Ianiro G. Fecal microbiota transplantation plus pembrolizumab and axitinib in metastatic renal cell carcinoma: the randomized phase 2 TACITO trial. Nat Med. 2026 Apr;32(4):1316-1324. doi: 10.1038/s41591-025-04189-2. Epub 2026 Jan 28.

    PubMed 41606119

  • Duttagupta S, Messaoudene M, Hunter S, Desilets A, Jamal R, Mihalcioiu C, Belkaid W, Marcoux N, Fidelle M, Suissa D, Ponce M, Geiger M, Malo J, Piccinno G, Puncochar M, Filin A, Heidrich V, Rusu D, Mbaye B, Durand S, Ben Aissa I, Puller V, de Lahondes R, Blais N, Tehfe M, Owen S, Belanger K, Parvathy SN, Shieh B, Raphael J, Lenehan J, Breadner D, Rothenstein J, Rozza N, Maillou J, Nili S, Prifti DK, Pinto F, Armanini F, Kim-Schulze S, Marron TU, Kroemer G, Derosa L, Zitvogel L, Silverman M, Segata N, Maleki Vareki S, Routy B, Elkrief A. Fecal microbiota transplantation plus immunotherapy in non-small cell lung cancer and melanoma: the phase 2 FMT-LUMINate trial. Nat Med. 2026 Apr;32(4):1337-1350. doi: 10.1038/s41591-025-04186-5. Epub 2026 Jan 28.

    PubMed 41606121

  • Fernandes R, Jabbarizadeh B, Rajeh A, Hong MMY, Baines KJ, Ernst S, Winquist E, Ali AS, Penny S, Figueredo R, Parvathy SN, Lenehan JG, Pinto DM, Silverman MS, Maleki Vareki S. Fecal microbiota transplantation plus immunotherapy in metastatic renal cell carcinoma: the phase 1 PERFORM trial. Nat Med. 2026 Apr;32(4):1325-1336. doi: 10.1038/s41591-025-04183-8. Epub 2026 Jan 28.

    PubMed 41606120

  • Bloom PP, Donlan J, Torres Soto M, Daidone M, Hohmann E, Chung RT. Fecal microbiota transplant improves cognition in hepatic encephalopathy and its effect varies by donor and recipient. Hepatol Commun. 2022 Aug;6(8):2079-2089. doi: 10.1002/hep4.1950. Epub 2022 Apr 5.

    PubMed 35384391

  • Quan X, Li Y, Wu H. Reply to "Probiotics for Hepatic Encephalopathy Prevention After TIPS: Still an Open Question". Liver Int. 2025 Nov;45(11):e70383. doi: 10.1111/liv.70383. No abstract available.

    PubMed 41047753

  • Li M, Li K, Tang S, Lv Y, Wang Q, Wang Z, Luo B, Niu J, Zhu Y, Guo W, Bai W, Wang E, Xia D, Wang Z, Li X, Yuan J, Yin Z, Trebicka J, Han G. Restoration of the gut microbiota is associated with a decreased risk of hepatic encephalopathy after TIPS. JHEP Rep. 2022 Feb 15;4(5):100448. doi: 10.1016/j.jhepr.2022.100448. eCollection 2022 May.

    PubMed 35313729

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Fecal Microbiota Transplantation and Rifaximin、Lactulose in people with Hepatic Encephalopathy and Fecal Microbiota Transplantation, run by Air Force Military Medical University, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guohong HAN, Professor (13991969930, 13991969930@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07454408, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

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