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Could a poop pill keep cirrhosis patients out of the hospital?

NCT ID NCT06461208

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Basildon University Hospital

    RECRUITING

    Basildon, SS16 5NL, United Kingdom

  • Bristol Royal Infirmary

    RECRUITING

    Bristol, BS2 8HW, United Kingdom

  • Broomfield Hospital

    RECRUITING

    Chelmsford, CM1 7ET, United Kingdom

  • Derriford Hospital

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Glasgow Royal Infirmary

    RECRUITING

    Glasgow, G4 0SF, United Kingdom

  • Hull Royal Infirmary

    RECRUITING

    Hull, HU3 2JZ, United Kingdom

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Ninewells Hospital

    RECRUITING

    Dundee, DD1 9SY, United Kingdom

  • Queen Elizabeth Hospital

    RECRUITING

    Gateshead, NE9 6SX, United Kingdom

  • Queen Elizabeth University Hospital

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Queen's Medical Centre

    RECRUITING

    Nottingham, NG7 2UH, United Kingdom

  • Raigmore Hospital

    RECRUITING

    Inverness, IV2 3UJ, United Kingdom

  • Royal Bournemouth Hospital

    RECRUITING

    Bournemouth, BH7 7DW, United Kingdom

  • Royal Derby Hospital

    RECRUITING

    Derby, DE22 3NE, United Kingdom

  • Royal Gwent Hospital

    WITHDRAWN

    Newport, NP20 2UB, United Kingdom

  • Southmead Hospital

    RECRUITING

    Bristol, BS10 5NB, United Kingdom

  • St. George's University Hospital NHS Foundation Trust

    RECRUITING

    London, SW17 0QT, United Kingdom

  • St. James University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • St. Mary's Hospital

    RECRUITING

    London, W2 1NY, United Kingdom

  • Torbay Hospital

    RECRUITING

    Torquay, TQ2 7AA, United Kingdom

  • University Hospital Hairmyres

    RECRUITING

    Glasgow, G75 8RG, United Kingdom

  • University Hospital Southampton

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

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