Cirrhosis of the Liver

The FMT (200mls) will be administered following preparation of the bowel with MoviPrep®, into the duodenum via a gastroscope derived from 50g of fresh donated stool from a healthy donor. The gastroscopy will be performed as per the King's College Hospital Gastroenterology Protocol.

Faecal microbiota transplantation

An identical appearing placebo solution (200mls 0.9% normal saline and 12.5% glycerol) will be administered into the duodenum via a gastroscope in a single blinded fashion following preparation of the bowel with MoviPrep®.

Placebo

King's College Hospital NHS Foundation Trust

Trial of Faecal Microbiota Transplantation in Cirrhosis

A Prospective, Randomised Placebo Controlled Feasibility Trial of Faecal Microbiota Transplantation in Cirrhosis

Assess recruitment rates and tolerability of FMT (e.g reflux rates):
>50% fulfil inclusion/exclusion criteria (of all screened- about 160)
>25% consent rate (of all those fulfilling inclusion/exclusion criteria about 80 patients)
>80% randomised patients treated successfully and completing study up to D90 (out of those randomised approx 22 patients)
Availability of obtaining sufficient donor samples for the study
Reflux rates of transplanted material <20% e.g. foul taste, foul smell, nausea, vomiting, indigestion.
Intolerable (resulting in withdrawal from the study GI side effects including diarrhoea, constipation, abdominal pain, flatulence and bloating) of <20%

Incidence of any transmissible bacterial or viral infection that is deemed to have been acquired from the donor including Clostridium Difficile infection
The development of any SAE/SAR or USAR that is not pre-specified or is a known consequence of disease progression or complication of cirrhosis as outlined in section 7.2.5.1 that: results in death/is life threatening/requires hospitalisation or prolongation of existing hospitalisation/results in persistent or significant disability or incapacity.

(i) Choosing the optimal primary outcome, and (ii) Estimating the parameters for sample size calculation.

All information, data and results obtained from study are confidential. Agreement from the Sponsor will be required prior to the public disclosure of any study-related data. It is expected that results from the study will be published in peer-reviewed scientific/medical journals and presented at scientific/clinical symposia and congresses. All publications and presentations relating to the study must be authorised by the CI.

xyloglucan/hemorrhage

Trial of Faecal Microbiota Transplantation in Cirrhosis

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