Could a poop pill protect the liver? trial tests fecal transplants against cirrhosis complications
NCT ID NCT06533852
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether fecal microbiota transplantation (FMT) — capsules containing processed stool from healthy donors — can slow the progression of decompensated cirrhosis, a severe form of liver disease. About 190 adults with advanced cirrhosis will receive either FMT or a placebo at the start and again after three months. Researchers will track how long it takes for serious complications like kidney injury, internal bleeding, or infections to occur, and whether the treatment improves survival without a liver transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fecal Microbiome Transplantation (FMT) — capsules containing processed stool from healthy donors
- What this could lead to
- If successful, this could offer a new way to delay or prevent serious complications of advanced liver disease, potentially reducing the need for liver transplants.
- What could go wrong
- This is an early-phase trial with 190 participants, so results may not apply to all patients. FMT carries risks of infection or immune reactions, and the long-term effects are unknown.
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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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 190 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: 1. Age ≥ 18 years old. 2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any etiology may be included except from patients with cirrhosis due to autoimmune hepatitis, and patients with cirrhosis due to cholestatic liver disease can only be included in the study if they present clinical decompensation of cirrhosis (i.e. ascites). 3. Child-Pugh B or C patients (7- up to 12 points). 4. Women of child-bearing potential\* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence\*\* (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function. Exclusion Criteria: 1. Previous history of gastrointestinal surgery or colorectal cancer. 2. Patients with previous history of intestinal obstruction or those who are at increased risk of this complication. 3. Active Clostridium Difficile infection. 4. Patients on treatment with non-selective beta-blockers for \<3 month or without stable doses. 5. Patients on treatment with any immunosuppressive drugs. 6. Patients on antiviral therapy for HCV or those who have received it within the last 12 months. 7. Patients on antiviral therapy for HBV therapy for \< 12 months. 8. Patients with hepatocellular carcinoma, except for patients with early HCC (BCLC-0 or BCLC-A) or patients with previous history of HCC and absence of recurrence 2 years after treatment. 9. Patients admitted to the hospital for acute decompensation of the disease. These patients could be included after discharged as long as they do not present any of the following events: 1. Bacterial infection within 10 days before study inclusion. 2. Gastrointestinal bleeding within 10 days before study inclusion. 3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the New-Haven classification. 10. Patients with ACLF according to the criteria published by Moreau et al. (Appendix 1). 11. Severe alcoholic hepatitis requiring corticosteroid therapy (MELD \> 20) in the last 6 months. 12. Patients with active alcohol consumption of more than 21 units per week. 13. HIV infection. 14. Patients with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD \>2, chronic kidney disease with serum creatinine \>2mg/dL or under renal replacement therapy. 15. Patients with current extra hepatic malignancies including solid tumours and hematologic disorders. 16. Patients with previous organ transplantation. 17. Pregnancy or breastfeeding. 18. Patients included in other clinical trials in the month before inclusion. 19. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study. 20. Refusal to give informed consent.
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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
8 sites. 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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Corporació Sanitaria Universitaria Parc Taulí
RECRUITINGSabadell, Spain
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Hospital Clínic de Barcelona
RECRUITINGBarcelona, Spain
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Hospital General Universitario Gregorio Marañón
RECRUITINGMadrid, Spain
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Hospital General Universitario Puerta de Hierro
RECRUITINGMadrid, Spain
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Hospital Universitari Vall Hebron
RECRUITINGBarcelona, Spain
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Hospital Universitario Marqués de Valdecilla
RECRUITINGSantander, Spain
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Hospital Universitario Ramón y Cajal
RECRUITINGMadrid, Spain
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Hospital de la Santa Creu i Sant Pau
RECRUITINGBarcelona, Spain
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