Could a poop pill keep cirrhosis patients out of the hospital?
NCT ID NCT06461208
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking capsules of processed donor stool (fecal transplant) can help people with liver cirrhosis avoid serious infections and hospital stays. About 300 adults with alcohol-related or fatty liver cirrhosis will receive either the transplant or a placebo and be followed for two years. The goal is to see if this treatment can boost the immune system and reduce the need for emergency care.
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 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- 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 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. Aged ≥ 18 years 2. Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and/or histological criteria. 3. MELD score 8-16 4. Patients with alcohol-related cirrhosis who must have an active alcohol consumption on average ≤20 grams/day \[1 unit of alcohol contains 10mLs or 8g of alcohol\]. 5. Patients must be deemed to have the capacity to provide written informed consent to participate. Exclusion Criteria: 1. Moderate, severe or life-threatening food allergy (e.g., peanut allergy) 2. Pregnancy or planned pregnancy\*. Urine testing will be performed at screening to rule out pregnancy in females. 3. Breast-feeding 4. Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation. 5. Active alcohol consumption of \>20 grams/day \[1 unit of alcohol contains 10mLs or 8g of alcohol\] 6. Had a previous liver transplant 7. Patients with inflammatory bowel disease. 8. Patients with coeliac disease. 9. Patients with a history of prior gastrointestinal resection or surgery that could change the gut microbiome or result in bacterial overgrowth e.g. gastric bypass 10. Active malignancy including hepatocellular carcinoma 11. Patients with an expected life expectancy \<6 months or listed for liver transplantation 12. Infected with HIV, hepatitis B or C \[patients who have undetectable hepatitis B or C DNA/RNA can be recruited\]. 13. Patients who have received antibiotics or probiotics (excluding food stuffs containing 'live bacteria' such as live yoghurts, kefir, fermented vegetables such as sauerkraut/kombucha or cheese) within 7 days prior to randomisation. 14. Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication. 15. Patients who have received another investigational drug or device within 4 months prior to randomisation. 16. Patients, who in the opinion of the PI, have a medical condition, or other relevant psychological, familial, or social factor that may jeopardise their health, compliance, or influence the trial integrity in any way.
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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
22 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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Basildon University Hospital
RECRUITINGBasildon, SS16 5NL, United Kingdom
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Bristol Royal Infirmary
RECRUITINGBristol, BS2 8HW, United Kingdom
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Broomfield Hospital
RECRUITINGChelmsford, CM1 7ET, United Kingdom
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Derriford Hospital
RECRUITINGPlymouth, PL6 8DH, United Kingdom
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Freeman Hospital
RECRUITINGNewcastle upon Tyne, NE7 7DN, United Kingdom
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Glasgow Royal Infirmary
RECRUITINGGlasgow, G4 0SF, United Kingdom
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Hull Royal Infirmary
RECRUITINGHull, HU3 2JZ, United Kingdom
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King's College Hospital NHS Foundation Trust
RECRUITINGLondon, SE5 9RS, United Kingdom
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Ninewells Hospital
RECRUITINGDundee, DD1 9SY, United Kingdom
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Queen Elizabeth Hospital
RECRUITINGGateshead, NE9 6SX, United Kingdom
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Queen Elizabeth University Hospital
RECRUITINGGlasgow, G51 4TF, United Kingdom
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Queen's Medical Centre
RECRUITINGNottingham, NG7 2UH, United Kingdom
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Raigmore Hospital
RECRUITINGInverness, IV2 3UJ, United Kingdom
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Royal Bournemouth Hospital
RECRUITINGBournemouth, BH7 7DW, United Kingdom
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Royal Derby Hospital
RECRUITINGDerby, DE22 3NE, United Kingdom
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Royal Gwent Hospital
WITHDRAWNNewport, NP20 2UB, United Kingdom
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Southmead Hospital
RECRUITINGBristol, BS10 5NB, United Kingdom
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St. George's University Hospital NHS Foundation Trust
RECRUITINGLondon, SW17 0QT, United Kingdom
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St. James University Hospital
RECRUITINGLeeds, LS9 7TF, United Kingdom
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St. Mary's Hospital
RECRUITINGLondon, W2 1NY, United Kingdom
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Torbay Hospital
RECRUITINGTorquay, TQ2 7AA, United Kingdom
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University Hospital Hairmyres
RECRUITINGGlasgow, G75 8RG, United Kingdom
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University Hospital Southampton
RECRUITINGSouthampton, SO16 6YD, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria in a capsule: a new attempt to calm a brain complication of cirrhosis
- Can a digital platform catch liver cancer sooner?
- Can a Two-Drug combo keep cirrhosis patients out of the hospital?
- Can removing the spleen help the liver fight cancer?
- Blood test may forecast which cirrhosis patients survive after discharge
- Can a parasite drug help fight a deadly gut infection in cirrhosis?