Small-scale ‘poo transplant’ trial shows promise in liver disease patients

Another large trial is set to start

The preliminary results have cleared the way for the next clinical study, "PROMISE."

About 300 people will be included in this research, and they will get FMT through capsules, eliminating the need for endoscopy. These capsules were created using "freeze-dried stool" from healthy donors. It will also investigate if the oral capsule can minimize the probability of contracting an infection, as well as its usefulness in improving gut health. 

“We are now expanding this trial nationally to 300 patients across the UK in the PROMISE trial. Patients told us that they would prefer to take tablets rather than have an endoscopy. The ‘crapsules,’ which have none of the taste or smell as the name suggests, may offer new hope for patients with cirrhosis who are out of treatment options,” said Professor Debbie Shawcross, who is chief investigator of the PROMISE trial. 

The PROMISE trial will enroll cirrhosis patients from all around the UK, including London, Wales, Gateshead, and Leeds. The PROMISE study will also be led by the King's College London and funded by a collaboration between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC).

FMT for cirrhosis

Cirrhosis, often known as end-stage chronic liver disease, is the third leading cause of death in the UK. The major treatment option for this condition is liver transplantation; however, it can only be done if the patients do not have any antibiotic-resistant infections. 

Patients with cirrhosis are found to be particularly at high risk of developing antimicrobial resistance. 

This is because the healthy gut bacteria in cirrhosis patients are rapidly replaced with the bad ones. This leaves them extremely sensitive to a variety of infections, many of which can be serious and even deadly.

Overuse of antibiotics to fight infections may worsen the situation in some cases and make the drugs less effective. Moreover, this can also make the bowel prone to superbug infections. The PROFIT trial demonstrates that harmful gut bacteria can be replaced with healthy bacteria using the FMT treatment. And if this larger trial shows effectiveness, then FMT could be widely used as a treatment for infections in cirrhosis patients, thereby significantly boosting their health. 

“PROMISE trial, a critical endeavor that will shed further light on the advantages of this treatment for individuals with cirrhosis who develop drug-resistant infections. This exciting new research also has wider implications – potentially in the future it could tackle antimicrobial resistance. Finding new, effective ways to treat resistant bacteria is one of the most important challenges in global medicine and this could provide a solution that could save healthcare systems across the world, millions of pounds,” said Pamela Healy, chief executive of the British Liver Trust who is a collaborator in the PROMISE trial.