healthmedicinet

A poop-filled pill designed to boost gut health and prevent serious infections is being given to hundreds of Britons as part of a trial.

Researchers announced the results of a first smaller study of 32 people who had undergone a fecal microbiota transplant at a conference in Vienna.

In 32 people with advanced cirrhosis of the liver, the ‘poop transplant’ was placed in their stomach through a tube in their nose.

After three months, the amount of good bacteria in the intestine increased and the intestinal barrier was strengthened. Researchers also said the volunteers had less of the deadly poison ammonia in their blood.

Now the same team at King’s College London has developed a ‘crapsule’ – a freeze-dried stool tablet donated by healthy volunteers to make it easier to take.

They are starting the new, larger five-year study called PROMISE to see if taking the tablets every three months for two years can reduce hospitalizations.

Lead researcher Professor Debbie Shawcross said patients with advanced cirrhosis were prone to nasty infections caused by ‘bad bacteria’ that landed them in intensive care.

But that was replaced by ‘good’ bacteria from the donors in the old study, which was called PROFIT.

‘We wanted to see if we changed the gut microbiome of a small group of people with liver disease, if we could improve the outcomes, especially their susceptibility to infection?’

The initial feasibility study was also done to see if the treatment was acceptable to patients.

Professor Shawcross, Professor of Hepatology and Chronic Liver Failure at King’s College London, said: ‘You can imagine there are potentially terrible things that people can have in their heads.

?But everyone was really into it and people generally felt a lot better about it.

“We showed that it was safe and feasible to do and that by altering the gut microbiome in patients with liver disease, we could potentially change the outlook and outcomes for these patients.”

In many cases, the only treatment for patients with cirrhosis is a liver transplant.

Professor Shawcross added: ‘The ‘crapsules’, which don’t have the taste or smell as the name suggests, may offer new hope to patients with cirrhosis who have run out of treatment options.’

The new research was unveiled at the European Association for the Study of the Liver (EASL) Congress 2023 taking place in Vienna.

Professor Shawcross said 16 centers in England, Scotland and Wales, including Newcastle, Liverpool, Leeds, Bristol, Plymouth and Portsmouth, are currently recruiting cirrhotic patients into the study.

The poop therapy ? known scientifically as Fecal Microbiota Transplantation ? will also be studied to see if it has an effect on diabetes and obesity.

The FMT transplants are currently being used in the NHS to treat hospital-acquired infection C. difficile which causes severe diarrhoea, but are being investigated in a number of conditions including arthritis, skin cancer and diabetes.

Her co-investigator Professor Lindsey Ann Edwards said it brought a renewed sense of hope to patients with advanced cirrhosis, offering a potential breakthrough in their treatment and survival.

The two women are working on the new trial, funded by the National Institute of Health Research UK (NIHR), with the British Liver Trust charity.

Cirrhosis – irreversible scarring of the liver, often caused by alcohol – is the third leading cause of death and loss of working life in the UK.

Pamela Healy, chief executive of the British Liver Trust, said: ‘We are delighted to support this innovative research that could become a life-changing treatment for patients.

Co-investigator Prof. Lindsey Ann Edwards said it brought a renewed sense of hope to patients with advanced cirrhosis, offering a potential breakthrough in their treatment and survival.

?Not only can untreatable infections themselves be serious, they can also lead to further serious complications.

“The researchers have worked with the Trust to ensure that patients are actively involved at all stages of the trial, from initial concept through design and delivery.”

She said the PROMISE trial was a “critical endeavor” that will shed more light on the benefits of this treatment for people with cirrhosis who develop drug-resistant infections.

The new research has wider implications for potentially addressing antimicrobial resistance, she added.

“Finding new, effective ways to treat drug-resistant bacteria is one of the most important challenges in global medicine and this could provide a solution that could save healthcare systems around the world millions of pounds.”

Liver specialist Thomas Berg, a professor of medicine at the University of Leipzig, Germany and secretary general of EASL, told the conference that the British research was “exciting.”

Dr. Berg added: “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 of liver health for years to come.”

Dr. Lindsey Edwards of King’s College London told the EASL press conference in Vienna that it was a “pretty rough” process.

‘We’re pooping. We puree it in a cocktail blender. We joke and say shaken, not stirred ? but you don’t drink it,” she said.

“It’s administered through an endoscopy or you can take it in capsules or we call them crapsules.”

‘It restores all your good bacteria. But the beauty of restoring those good bacteria is that it restores all those enzymes and it essentially reprograms you metabolically.”

She explained that reducing infections was vital for liver patients. ‘Infections in liver patients are fatal for two reasons. They either die with the infection or they are cut from transplant, which is a last resort.

“So it’s very important to try to prevent these patients from getting infections.”

She said it was also important because it means the vulnerable patients don’t fall victim to antibiotic resistance.

?What we do is strengthen your immune system so you don’t get as many antibiotics. That is also very important, because next to liver disease, antimicrobial resistance is one of the biggest health problems worldwide.’

Aleksander Krag, vice-secretary of EASL and a liver specialist in Denmark said it was a ‘wonderful example of how deeper understanding of changes in technology can suddenly lead to entirely new ways we can understand and help patients in new ways’.

In the first trial, patients were given the FMT for 30 days, and in the second trial, they were given the crapsules for three years and then followed for two years.

All donors were on a vegan or vegetarian diet – coincidentally not designed – and were carefully screened for 26 diseases, including Covid-19.

Dr. Edwards said, ?They also go through a lot of different tests, lifestyle, questionnaires, things like that. So make sure there’s nothing we’re broadcasting.?

See for more information about the trial https://www.fmt-trials.org/promise/faqs-2/