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A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis

ConditionLiver Cirrhosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College London

About this trial

A feasibility trial called PROFIT has previously shown that FMT administered endoscopically into the jejunum in patients with cirrhosis is safe and feasible and have identified some potential mechanisms of action that warrant further interrogation. The aim of the PROMISE Trial is to evaluate the efficacy and mechanisms of action of encapsulated FMT (versus placebo) to reduce infection and mortality in patients with alcohol-related and metabolic dysfunction-Associated Steatotic Liver (MASLD) cirrhosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥ 18 years

Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and/or histological criteria.

MELD score 8-16

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].

Disqualifiers

Moderate, severe or life-threatening food allergy (e.g., peanut allergy)

Pregnancy or planned pregnancy*. Urine testing will be performed at screening to rule out pregnancy in females.

Breast-feeding

Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Encapsulated FMT

    Drug

    Encapsulated Faecal Microbiota Transplant

  • Placebo

    Other intervention

    The placebo product contains microcrystalline methylcellulose. It is supplied as a size 0, Swedish Orange Delayed-Release capsule (DRCap) and provides a complete match with regards to the appearance (e.g., dimensions, colour) to the FMT capsules.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Encapsulated FMTExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Defined infection resulting in presentation to the emergency department or hospital admission (time to event)

To evaluate the efficacy of encapsulated FMT to reduce the susceptibility of infection in patients with cirrhosis measured by the time to first infection resulting in presentation to the emergency department or hospitalisation.

Time frame
From date of randomisation until the date of first hospitlisation, assessed up to Month 24.
2

Defined Decompensation episode resulting in presentation to emergency department or hospital admission (time to event)

Decompensation episodes of the following: 1. New onset moderate or large volume ascites requiring diuretic therapy or paracentesis 2. Variceal Bleeding confirmed following emergency endoscopy or on CT angiography suggestive of bleeding elsewhere in the gastrointestinal tract as a consequence of portal hypertension. 3. Overt hepatic encephalopathy (Westhaven Criteria grade 2-4)

Time frame
From date of randomisation until the date of first hospitalisation, assessed up to Month 24.

Secondary outcomes

1

Time to first infection resulting in hospitalisation over 24 month follow up period

(former primary endpoint)

Time frame
Screening - End of Visit (Month 24)
2

Incidence of decompensating events

All types of decompensating events will be included: 1. hepatic encephalopathy 2. new-onset or worsening ascites 3. variceal bleeding

Time frame
Screening - End of Visit (Month 24)
3

All-cause infection

Including infections not resulting in hospitalisation

Time frame
Screening - End of Visit (Month 24)
4

Progression to ACLF (Acute on Chronic Liver Failure) i.e. the development of one or more organ failure

Time frame
Screening - End of Visit (Month 24)

Other outcomes

Sponsors and contacts

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King's College London

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborator

Imperial College London

Collaborator

BRITISH LIVER TRUST

Collaborator

King's College Hospital NHS Trust

Collaborator

St George's Healthcare NHS Trust

Collaborator

Source ClinicalTrials.gov
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