Tag: faecal microbiota transplantation

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Faecal Transplant Pills Show Promise in Clinical Trials for Multiple Types of Cancer

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Two Canadian clinical trials show poop pills could help patients respond to immunotherapy while also reducing toxic side effects of cancer drugs

Faecal microbiota transplants (FMT), can dramatically improve cancer treatment, suggest two groundbreaking studies published in the prestigious Nature Medicine journal. The first study shows that the toxic side effects of drugs to treat kidney cancer could be eliminated with FMT. The second study suggests FMT is effective in improving the response to immunotherapy in patients with lung cancer and melanoma.

The findings represent a giant step forward in using FMT capsules – developed at Lawson Research Institute (Lawson) of St. Joseph’s Health Care London and used in clinical trials at London Health Sciences Centre Research Institute (LHSCRI) and Centre de recherche du Centre hospitalier de l’Université de Montréal (CRCHUM) – for safe and effective cancer treatment.

A Phase I clinical trial was conducted by scientists at LHSCRI and Lawson to determine if FMT is safe when combined with an immunotherapy drug to treat kidney cancer. The team found that customised FMT may help reduce toxic side effects from immunotherapy. The clinical trial involved 20 patients at the Verspeeten Family Cancer Centre at London Health Sciences Centre (LHSC).

“Standard treatment for advanced kidney cancer often includes an immunotherapy drug that helps the patient’s immune system tackle cancer cells,” says Saman Maleki, PhD, Scientist at LHSCRI. “But, unfortunately, the treatment frequently leads to colitis and diarrhoea, sometimes so severe that a patient must stop life-sustaining treatment early. If we can reduce toxic side effects and help patients complete their treatment, that will be a gamechanger.”

Separate Phase II lung and skin cancer studies were led by researchers at CRCHUM in collaboration with Lawson and LHSCRI. The studies found that 80 per cent of patients with lung cancer responded to immunotherapy after FMT, compared to only 39-45 per cent typically benefiting from immunotherapy alone. Similarly, 75 per cent of patients with melanoma who received FMT experienced a positive response to treatment, compared to only 50-58 per cent response in patients who receive immunotherapy alone. Twenty patients participated in the lung cancer clinical trial and 20 patients participated in the skin cancer clinical trial.

“Our clinical trial demonstrated that faecal microbiota transplantation could improve the efficacy of immunotherapy in patients with lung cancer and melanoma,” says Dr Arielle Elkrief, co-principal investigator and Physician Scientist, Université de Montréal-affiliated hospital research centre (CRCHUM). “The results also uncovered one possible mechanism of action of faecal transplantation – through the elimination of harmful bacteria following the transplant. Our results open up a novel avenue for personalised microbiome therapies, and faecal transplant is now being tested as part of the large pan-Canadian Canbiome2 randomised controlled trial.”

“Faecal microbiota transplantation in melanoma and lung cancer opens an entirely new therapeutic avenue, made possible by the exceptional commitment of our patients and the teamwork,” adds Dr. Rahima Jamal, Director of the Unit for Innovative Therapies (UIT) at CRCHUM. “At the Unit for Innovative Therapies (UIT) of the CRCHUM, we have had the privilege of translating laboratory discoveries into early phase clinical trials and witnessing their concrete impact on people living with cancer.”

Both studies use advanced, world-leading FMT capsules, also known as LND101, produced by Lawson in London, Ont. The research reinforces London’s place as a global leader in FMT innovation and treatment. The capsules are processed from healthy donor stools and ingested to help restore a patient’s healthy gut microbiome and treat different types of cancer.

“To use FMT to reduce drug toxicity and improve patients’ quality of life while possibly enhancing their clinical response to cancer treatment is tremendous, and it had never been done in treating kidney cancer before this,” says Dr Michael Silverman, Scientist at Lawson and Head of St. Joseph’s Infectious Diseases Program. “And none of this would be possible if not for this close collaboration: innovating the FMT capsules in Lawson labs and introducing them at LHSCRI and CHUM to advance vital research initiatives. Also, because LND101 comes from healthy donors, production can be scaled up to eventually help large numbers of cancer patients.”

The studies build on earlier London and CHUM-generated Phase I research showing FMT can safely augment treatment for people with melanoma. FMT is also being studied in people with pancreatic cancer and triple-negative breast cancer, and is already a well-established treatment for serious gut infections such as C. difficile, which can cause severe diarrhoea.

“Our hope is that our research will one day help people with cancer live longer while reducing the harmful side effects of treatment,” adds Dr Ricardo Fernandes, Scientist at LHSCRI and Medical Oncologist at LHSC. “We are world leaders in FMT research and we’re excited about its potential.”

Source: London Health Sciences Centre Research Institute

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Treatment for Resolving C. Diff Infection ‘So Effective’ that Trial Discontinued

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Clostridioides difficile. Source: CDC

In a clinical trial, researchers found that, after a course of vancomycin, faecal microbiota transplantation (FMT) resolved Clostridioides difficile infections significantly more effectively than standard care alone. The treatment was so effective that further participant recruitment was halted. The findings were published in The Lancet Gastroenterology and Hepatology.

The results of the randomised, double-blind, placebo-controlled trial are extremely encouraging, said Simon Mark Dahl Baunwall, a PhD student at the Department of Clinical Medicine and a doctor at Aarhus University Hospital.

“Our new study shows that we can effectively cure the infection through the early use of faecal microbiota transplantation (FMT) after completing the standard treatment, to prevent relapses,” he said.

Few treatment options are available for the urgent threat of C. diff infections. Microbiota restoration with faecal microbiota transplantation is an effective treatment option for patients with multiple recurring episodes of C. diff. The researchers compared the efficacy and safety of faecal microbiota transplantation compared with placebo after vancomycin for first or second C. diff infection.

At a Danish hospital, 42 eligible patients with first or second C. difficile infection were randomly assigned to either faecal microbiota transplantation or placebo administered on day 1 and between day 3 and 7, after they had received 125mg oral vancomycin four times daily for 10 days. The primary endpoint was resolution of C difficile-associated diarrhoea (CDAD) eight weeks after treatment, with patients followed for eight weeks or until recurrence.

Due to the efficacy The primary outcome and safety outcomes were analysed in the intention-to-treat population, which included all randomly assigned patients.

Findings

The trial was stopped after the interim analysis done on April 7, 2022 for ethical reasons because the placebo group had a much lower rate of resolution at week 8 (33%) than the treatment group (90%). The absolute risk reduction was 57%.

“In rare cases, it can happen that you discover that the treatment you are investigating is so effective that it is ethically indefensible to continue,” said Baunwall.

“Our study is one example, in that the new FMT treatment is so much better than the standard treatment with antibiotics that it would be unethical to continue, because the patients in the control group would risk not receiving the FMT treatment.”

Overall, 204 adverse events occurred, with one or more adverse events being reported in 20 of 21 patients in the FMT group and all 21 patients in the placebo group, with the most common being diarrhoea and abdominal pain.

Interpretation

The study authors concluded that FMT in patients with first or second C. diff infection, is highly effective and superior to the standard of care vancomycin alone in achieving sustained resolution from C. diff.

Source: Aarhus University

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Faecal Microbiota Transplantation is Effective for Recurrent C. Diff

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C difficile. Source: CDC

Research just published in Clinical Infectious Diseases has found that Faecal Microbiota Transplantation, or FMT, is an optimal cost-effective treatment for first recurrent Clostridioides difficile infection (CDI).

“The most effective therapies for CDI are also the cost effective therapies,” said co-investigator Radha Rajasingham, MD. “FMT should be moved earlier in the treatment algorithm for CDI. Our model suggests it is effective and cost effective when used in patients after a single episode of recurrent CDI.”

Mathematical modelling was used to understand both the effectiveness and cost effectiveness of earlier use of FMT in the treatment of CDI, which normally arises from the disruption of healthy gut bacteria.

While this disease is caused by antibiotics, it is often treated with antibiotics, including fidaxomicin for initial, non-severe CDI or vancomycin for severe CDI, followed by FMT for any recurrent CDI.s. Unfortunately in many cases, CDI recurs in the same person again. This cycle of infection is called recurrent CDI.

Current guidelines recommend using FMT as a last resort for people with recurrent CDI. The goal of this research was to examine the benefits of using FMT earlier in the cycle of CDI.

“Based on this analysis, we would recommend that rather than waiting for multiple recurrent CDI, providers should consider FMT use for any recurrent CDI,” said co-author Byron Vaughn, MD, MS.

The authors suggest future research examine the role of FMT to prevent all recurrent CDI or even as primary prevention of CDI in high risk individuals.

Source: University of Minnesota Medical School