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Improve melanoma treatment with fecal transplant?

Improve melanoma treatment with fecal transplant?

Using immune checkpoint inhibitors like pembrolizumab or nivolumab in conjunction with fecal transplants demonstrated the procedure’s safety in patients with advanced melanoma, according to a phase 1 clinical trial.

65% of the trial participants experienced a favorable response to immunotherapy. Following the fecal transplant, positive responders’ gut microbiomes revealed a rise in helpful bacteria and a decrease in dangerous bacteria.

Larger phase 2 trials will be carried out, and the use of faecal transplants in difficult-to-treat malignancies like pancreatic cancer will be investigated.

Numerous cancer patients have recently benefited from a type of treatment called immunotherapy, which uses the immune systems of the patients to identify and eliminate cancer cells.

Some immunotherapy medications, such as pembrolizumab (Keytruda) and nivolumab (Opdivo), function by preventing the mechanism by which cancer cells can conceal themselves from the immune system.

These immune checkpoint inhibitors, also known as anti-programmed death (PD-1) medications, are successful in treating roughly 50% of patients with melanoma, a kind of skin cancer.

Recently, researchers investigated whether patients with metastatic melanoma might respond better if immunotherapy and fecal microbiota transplants were combined.

This combination was not only risk-free but most patients responded well to the therapy, with some obtaining complete remission.

Phase 1 of the trial

Faecal transplants were coupled with the licenced medications pembrolizumab or nivolumab, which are already the standard of care for advanced melanoma, in the phase 1 MIMic trial.

The objective of the clinical experiment was to determine whether it is secure to combine these two medications in melanoma patients. As a supplementary goal, the impact of faecal transplants on the immune system and gut flora was evaluated.

Following a technique that was approved by Health Canada, healthy donors were carefully chosen. Then, capsules were created using the faeces of healthy donors.

Twenty metastatic melanoma patients were enrolled in the trial from Lawson Health Research Institute, the Jewish General Hospital (JGH), and the Centre Hospitalier de l’Université de Montréal (CRCHUM).

Each research subject was given capsules containing 80–100 mg of a fecal transplant from a single healthy volunteer donor. At least a week before receiving treatment with approved immunotherapy medications (either pembrolizumab or nivolumab), the fecal transplants were administered orally as capsules.

Is fecal transplantation plus immunotherapy safe?

The faecal transplantation operation was successfully completed by each of the 20 patients.

No major side effects were noticed prior to beginning immunotherapy, and no infections were spread through faecal transplantation. However, eight patients (40%) did have mild to moderate side effects from faecal transplantation, including diarrhoea, flatulence, and abdominal discomfort.

17 patients (85%) of the group encountered adverse immune-related events, the majority of which (70%) happened within the first three months of immunotherapy. Of these, five study participants (25%) experienced significant immune-related adverse effects, including nephritis (n = 1), arthritis (n = 2), exhaustion (n = 1), pneumonitis (n = 1), and arthritis (n = 2). These side effects forced the study participants to stop receiving their medication.

The researchers found no previously unreported adverse reactions to immunotherapy or faecal transplantation.

Did combined therapy lead to better results?

Four of the 20 participants in the trial (20%) experienced complete remission, making up 65% (13 out of 20) of the patients who responded favorably to the therapy.

All patients had strains of the donor’s bacteria in their gut microbiomes, according to analysis; however, this resemblance only got stronger over time in those patients who had a good response to the therapy. After receiving faecal transplants, respondents had higher levels of helpful bacteria and lower levels of dangerous bacteria.

The good impact of healthy donor faeces in boosting the efficiency of immunotherapy was further demonstrated in studies on mice by the researchers.

Fecal microbial transplantation: what is it?

Fecal transplantation, also known as fecal microbial transplantation (FMT), is a medical treatment in which the recipient’s intestines are filled with a healthy person’s donated poo (or feces).

In order to address medical disorders linked to abnormalities in gut bacteria, this method involves introducing healthy bacteria into the recipient’s intestines.

The effective treatment for recurrent Clostridium difficile infections is fecal transplantation. Fecal transplants are frequently administered via colonoscopy, however they can also be given as pills.

Gut and immune system interaction

So why do immune checkpoint inhibitors not work for everyone?

Recent research reveals that the bacteria in the gut may have an impact on how well the medications work. Immune checkpoint inhibitor-responsive individuals have a distinctive and healthy gut microbiome, often known as a “group of microorganisms in their gut.”

One of the study’s authors, Saman Maleki, Ph.D., assistant professor of oncology, pathology and laboratory medicine, and medical biophysics at Western University, as well as a researcher at the London Regional Cancer Programme and Lawson Health Research Institute, reasoned that altering a person’s gut microbiome to make it more diverse and healthy may enhance their response to immune checkpoint inhibitors.

Faecal microbial transplantation is one technique to modify the gut microbiota.

Will fecal transplants be used in the management of melanoma?

The principal study investigator, Dr. John Lenehan, a medical oncologist at the London Regional Cancer Programme, an associate scientist at the Lawson Health Research Institute, and an associate professor of family medicine and oncology at Western University, stated that the most significant finding in the study was that “none of the patients were harmed by the experimental treatment.”

Faecal transplants had been demonstrated to be beneficial by observational and pre-clinical studies, but “what happens in mice does not always translate to patients,” he noted. In fact, according to Dr. Lenehan, “more recent studies using similar therapies have shown harm, with patients having a worse response.”

He clarified that faecal transplantation was carried out differently in these other investigations than it was in the MIMic experiment.

“There are several factors, including bowel preparation, the number of FMTs required, the amount of stool required, and the identity of the donors. We had no idea if our approach would be secure or efficient. Thankfully, it appears that it was both! “, he exclaimed.

The director of the Supportive Oncology Research Group at the University of Adelaide and a research fellow at the Hospital Research Foundation Group, Hannah Wardill, Ph.D., who was not involved in this study, thinks this combination therapy strategy has the potential to be a successful treatment.

FMT is a reasonably accessible intervention, and this study shows it is safe and likely effective at improving immunotherapy response,” she added.

The combination of faecal transplants and immunotherapy results in an improved response rate in patients who would otherwise be unresponsive to immunotherapy, which indicates that “more people will benefit from immunotherapy,” according to Dr. Wardill.


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A trial of fecal transplant offers hope for liver illness.

A trial of fecal transplant offers hope for liver illness.

Fecal transplants may be a successful treatment for persons with end-stage chronic liver disease. This is according to research from Europe.

The “good” bacteria from a healthy donor are used to replace the “bad” bacteria in the gut microbiome.

The use of fecal transplant pills to treat C. difficile infection is authorized in the US. Numerous more potential uses for fecal transplantation exist in addition to cirrhosis studies.

For those with chronic liver disease, a new study into fecal transplants may change the game. After promising results from the first experiment, known as the PROFIT trial. A team led by King’s College London is about to start a clinical trial there known as the PROMISE trial.

Today at the 2023 EASL (European Association for the Study of the Liver) Congress in Vienna, Austria, the results of the PROFIT experiment. These have not yet been published in a peer-reviewed publication, were presented.

Although fecal transplants are safe and effective, there are other therapy choices for cirrhosis patients. According to the trial’s researchers, who believe their data will open up more possibilities.

Using a capsule to deliver a fecal transplant

Gastroenterologist and internal medicine specialist Dr. Daniel Freedberg is a member of the Peggy Lillis Foundation’s scientific advisory council and an assistant professor of medicine and epidemiology at Columbia University’s Mailman School of Public Health in New York.

Records of fecal transplants date back centuries, according to Freedberg, who is not a participant in the clinical trial, who spoke to us.

“More recently, we have two decades of experience using faecal transplants for recurrent Clostridioides difficile (C. difficile) infection,” the doctor said. “Faecal transplants transfer stool from a healthy person to a sick person. The theory is that the injured gut bacteria will be replaced by normal, healthy bacteria, aiding in the recovery of health. Faecal transplants can be performed orally, colonoscopically, upper endoscopically, or through an enema. Faecal transplants can be delivered in all of these ways with success.”

The PROFIT trial’s researchers discovered that patients preferred taking a tablet to the other, more invasive techniques. Even though each one may be successful.

Patients told researchers that they would rather take pills than undergo an endoscopy to provide the fecal transplant, according to Debbie Shawcross, chief investigator of the PROMISE trial and professor of hepatology at Kings College London.

She noted that for patients with cirrhosis who have exhausted all other therapy choices, “the ‘capsules,’ as they are sometimes called. This have no taste or smell as the name suggests, may offer new hope.”

The “bad” bacteria that is present in the bodies of persons with cirrhosis of the liver may be effectively replaced by taking the capsules. These are filled with freeze-dried stool rich in “good” bacteria, according to the research.

While further research is required, fecal transplants may one day be a viable alternative to liver transplantation for some patients.

Trial of faeces transplant will be expanded

There will be 300 individuals with liver disease participating in the new experiment, which will begin in the UK. The current trial is different from the last one in that there are 300 participants instead of 32, a larger study sample. Half of the patients will ingest freeze-dried fecal matter capsules, or “crapules,” instead of having an endoscopy. The other half will take a placebo.

Fortunately, the ‘capsules’ don’t taste or smell as their name might imply. This kind of treatment is far less invasive than an endoscopy, which is advantageous to patients.

Over 21 days, the participants will take five capsules of medication (either FMT or placebo). Each at intervals of 91 days (every three months).

In contrast to the prior study, which only tracked patients for 90 days, the current trial permits the researchers to evaluate participants over 2 years. This provides for a more thorough investigation of the medication’s impact.

A healthy donor is used to provide the feces, who is then thoroughly examined for bacterial and parasite diseases, Covid-19 and other infections, as well as their risk factors.

Samples of blood, feces, and urine will also be taken at the time of recruitment and again after three, six, and twelve months. Following that, the samples will be examined for a variety of biomarkers,. This includes cytokine production, indicators of barrier integrity, a global metabolite profile, and fecal proteomics.


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