This unconventional treatment approach aims to boost gut health and reduce serious infections, paving the way for potential breakthroughs in liver disease management.
Professor Debbie Shawcross, Chief Investigator of the study, disclosed that the results of a smaller pilot study of 32 participants who underwent a fecal microbiota transplant were encouraging. This preliminary study, titled PROFIT, showed a rise in the levels of beneficial bacteria and reinforcement of the gut barrier, alongside a decrease in harmful ammonia levels in the participants' blood.
The patients with advanced cirrhosis had the stool transplant delivered to their stomachs via a tube down their nose. Cirrhosis – an irreversible scarring of the liver, typically induced by alcohol consumption – represents the third largest cause of mortality and loss of working life in the United Kingdom. In many instances, the standard treatment option for these patients is a liver transplant.
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According to Professor Shawcross, patients suffering from advanced cirrhosis are susceptible to severe infections due to the proliferation of harmful bacteria, often resulting in intensive care admission. The fecal microbiota transplant replaced these harmful bacteria with beneficial ones from healthy donors.
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"We wanted to see if we changed the gut microbiome of a small group of people with liver disease, could we improve outcomes, particularly their susceptibility to infection?" said Shawcross. As she further explained, the study aimed not only to examine the efficacy of the treatment but also to understand its acceptability to patients, who responded positively.
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Professor Shawcross and her team at King's College London are embarking on a more extensive five-year study, PROMISE, to see if these 'crapsules' taken every three months for two years can minimize hospital admissions. The professor expressed optimism, stating that these capsules, despite their colloquial name, could offer new hope for patients with cirrhosis who have exhausted other treatment options.
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The research was unveiled at Vienna's European Association for the Study of the Liver (EASL) Congress 2023. The PROMISE trial will involve 16 centers across England, Scotland, and Wales, including Newcastle, Liverpool, Leeds, Bristol, Plymouth, and Portsmouth, recruiting patients with liver cirrhosis.
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In addition, the potential benefits of fecal microbiota transplant – or 'poo therapy' – will be examined for diabetes and obesity. Currently used in the NHS for treating severe diarrhea caused by C.difficile infection, FMT transplants are also being explored in the context of several conditions, including arthritis, skin cancer, and diabetes.
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Professor Lindsey Ann Edwards, co-researcher on the study, highlighted the potential of the research to bring renewed hope to patients with advanced cirrhosis. The study, funded by the National Institute of Health Research UK (NIHR) and in collaboration with the British Liver Trust charity, could signal a potential breakthrough in treatment and survival.
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Pamela Healy, CEO of the British Liver Trust, supported the research. "We are delighted to support this innovative research that could become a life-changing treatment for patients," she said. The PROMISE trial represents a 'critical endeavour' that could highlight the benefits of this treatment for cirrhotic patients who develop drug-resistant infections, she added.
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The research could also have broader implications for tackling antimicrobial resistance, one of the most pressing challenges in global medicine. "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," Healy emphasized.
Notably, the patient-focused approach of the research has been praised. "The researchers have worked with the Trust to ensure that patients have been actively involved in all the stages of the study from its initial conception through to design and delivery," Healy explained.
The global medical community's prominent voices echo Healy's enthusiasm for the research. Liver specialist Thomas Berg, Professor of Medicine at the University of Leipzig, Germany, and Secretary-General of EASL, characterized the British research as 'exciting.'
Dr. Berg elaborated, "This study confirms the growing awareness in recent times of the link between gut health and liver disease and will be key to our scientific understanding around liver health for years to come."
Dr. Lindsey Edwards, from King's College London, provided insight into creating the 'crapsules' during the EASL press conference in Vienna. "We take poop. We mash it up in a cocktail blender. We joke and say shaken not stirred - but you don't drink it," she remarked.
Dr. Edwards went on to explain the potential benefits of the treatment. "It restores all of your good bacteria. But the good thing in restoring those good bacteria is it restores all of those enzymes and it metabolically reprogrammes you, essentially," she said.
Dr. Edwards explained that reducing infections for liver patients is crucial due to their potentially lethal effects and the risk of being removed from the transplant list. The treatment also stands to be significant in combating the widespread problem of antibiotic resistance. "We're bolstering your immune system so you don't need as many antibiotics," she stated.
Aleksander Krag, Vice-Secretary of EASL and a liver specialist in Denmark hailed the research as a 'beautiful example of how deeper understanding changes in technology can suddenly lead to whole new avenues of how we can understand and help patients in new ways.'
The trial's first phase provided patients with the fecal microbiota transplant on day 30. In the second study, patients will receive the crapsules for three years, followed by a two-year follow-up period.
All donors in the study followed a vegan or vegetarian diet, although this was coincidental rather than by design. The donors underwent rigorous screening for 26 illnesses, including COVID-19, and comprehensive lifestyle assessments. "They also undergo lots of different testing, lifestyle, questionnaires, all of that kind of thing. So make sure there is nothing that we're transmitting across," said Dr. Edwards.
With the promise of groundbreaking results in liver disease treatment and the potential for broader applications in combating conditions such as diabetes and obesity, the PROMISE trial represents a significant stride towards more innovative and effective healthcare solutions.
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