Trial of Faecal Microbiota Transplantation in Cirrhosis (PROFIT)
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|ClinicalTrials.gov Identifier: NCT02862249|
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : August 13, 2019
Patients with advanced cirrhosis have enteric dysbiosis with small bowel bacterial overgrowth and translocation of bacteria and their products across the gut epithelial barrier. This culminates in systemic inflammation and endotoxemia which induces innate immune dysfunction predisposing to infection and development of complications such as bleeding, sepsis and hepatic encephalopathy. It also plays a key role in the natural history of cirrhosis by influencing the rate of progression to advanced liver disease and terminal liver failure.
The investigators propose an intervention utilising Faecal Microbiota Transplantation (FMT) from a healthy donor to modify the gut microbiome alleviating gut dysbiosis and immune dysfunction. This may ultimately reduce the progression to chronic liver failure and the development of infection and organ dysfunction.
The primary objective of this study will be to assess whether stabilising gut dysbiosis with FMT in patients with advanced cirrhosis is both feasible and safe.
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis of the Liver||Biological: Faecal microbiota transplantation Biological: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Prospective, Randomised Placebo Controlled Feasibility Trial of Faecal Microbiota Transplantation in Cirrhosis|
|Actual Study Start Date :||March 27, 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Faecal microbiota transplantation
Faecal microbiota transplantation.
Biological: Faecal microbiota transplantation
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.
Placebo Comparator: Placebo
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®.
- Assessment of the feasibility of FMT [ Time Frame: 18 months ]
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%
- Assessment of the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 18 months ]
- 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 220.127.116.11 that: results in death/is life threatening/requires hospitalisation or prolongation of existing hospitalisation/results in persistent or significant disability or incapacity.
- To provide preliminary evidence of efficacy for a larger randomised trial [ Time Frame: 18 months ](i) Choosing the optimal primary outcome, and (ii) Estimating the parameters for sample size calculation.
- To estimate the costs and resources required to implement this novel therapy in a NHS environment. [ Time Frame: 18 months ]Cost effectiveness
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862249
|Contact: Debbie Shawcrossfirstname.lastname@example.org|
|Contact: Charlotte Woodhouseemail@example.com|
|King's College Hospital NHS Foundation Trust||Recruiting|
|London, United Kingdom, SE5 9RS|
|Contact: Charlotte Woodhouse firstname.lastname@example.org|
|Study Chair:||Debbie Shawcross||King's College London|