PROFIT
Research type
Research Study
Full title
A prospective, randomised placebo controlled feasibility trial of faecal microbiota transplantation in cirrhosis
IRAS ID
197237
Contact name
Deborah Shawcross
Contact email
Sponsor organisation
King's College London
Eudract number
2017-003629-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Our body contains trillions of microscopic organisms called bacteria which play an important role in keeping us healthy. These bacteria live mainly in our bowel and help our immune system fight infection. Liver disease is becoming more common in the UK and repeated liver damage causes the liver to be shrunken and scarred. This is known as cirrhosis. There are increased numbers of bowel bacteria in patients with cirrhosis with more ‘unfriendly’ bacteria which emit substances which disrupt the immune system. These patients often develop severe infections which result in them being hospitalised and often dying. Antibiotic treatment is prescribed but sometimes this is ineffective. It could be beneficial to replace the unhealthy bowel bacteria in patients with cirrhosis with bacteria donated from a healthy person by performing a type of bowel bacteria transplant. This is safe but has never been undertaken in patients with cirrhosis. This involves flushing out ‘unfriendly bacteria’ and replacing them during a gastroscopy with bacteria donated from a healthy person who has been carefully screened similar to blood donors. A gastroscopy involves passing a thin flexible camera through the mouth, down the gullet into the small bowel where the bacteria transplant is placed. This is a safe procedure and serious complications are uncommon.
This study will examine whether this is a feasible treatment that is both safe and palatable to patients without any adverse effects. It will also examine whether treatment may improve the health of patients with cirrhosis preventing them developing infections. Twenty four patients will receive a bacteria transplant and eight an identical transplant without bacteria known as a ‘placebo’. Patients will have blood and stool samples collected before, and after the transplant, (1 week, 1 and 3 months) to assess what impact the transplant has on their bowel bacteria and their immune system.
REC name
London - South East Research Ethics Committee
REC reference
17/LO/2081
Date of REC Opinion
31 Jan 2018
REC opinion
Further Information Favourable Opinion