Gut microbes’ vital role in maintaining good health is widely recognized and supported by a growing body of evidence. These microorganisms, which include bacteria, fungi, and viruses, have been shown to influence various aspects of our well-being, from organ function and mood to disease risk. Maintaining a balanced community of microorganisms in the digestive tract is crucial for our overall health, as an imbalance can lead to illness. While our diet plays a significant role in influencing this balance, therapeutically targeting gut bacteria is also possible.
One such therapeutic approach is fecal microbiota transplantation (FMT), which is used to treat Clostridioides difficile (C. diff) infection, a condition that causes severe diarrhea. FMT rebalances gut bacteria by introducing fecal matter from a healthy donor into the patient’s gastrointestinal tract. However, scientists have taken this a step further by developing therapies that specifically target gut bacteria. These therapies, designed as safer and more convenient alternatives to FMT for C. diff infections, contain live bacteria and are currently in the clinical trial phase. Several of these therapies have recently been approved by drug regulators in the United States and Australia.
Experts suggest that these advancements are paving the way for a future where pharmaceuticals directly target the gut microbiome, potentially treating a range of conditions linked to gut bacteria, such as arthritis, metabolic syndrome, and even cancer. Dr. Tanya Monaghan, a clinical associate professor and honorary consultant in gastroenterology at Nottingham University, describes the recent medication approvals as a paradigm shift, demonstrating that microbiome-based therapies can now navigate the complex regulatory process and reach patients.
To address concerns about the potential transfer of harmful compounds during FMT, scientists are now able to remove bacteria from donor feces without compromising the effectiveness of the treatment. Dr. Monaghan explains that research shows bacteria-free stool transplants remain effective against C. diff infection thanks to viral particles and other molecules present in the donor samples. Additional trials are comparing FMT with a new approach called fecal filtrate transplantation (FFT), which holds promise for reducing risks and standardizing treatment by eliminating the need to transplant live microbes.
The focus on targeting C. diff infection is not arbitrary. Dr. Mona Bajaj-Elliott, an ex-chair of the British Society of Gastroenterology Gut Microbiota for Health expert panel, explains that C. diff is a challenging bacterium to treat due to its ability to form inactive spores and travel through the environment, infecting humans without damage. Disruption of the gut microbiome balance can allow C. diff to multiply and produce toxins that attack the gut lining, causing symptoms such as cramps, fever, nausea, and diarrhea. Antibiotics can disturb this balance, making the infection particularly common in older people in hospitals or care homes and those with compromised immune systems. The resilience of C. diff spores to antibiotics and antiseptics contributes to the rapid spread of the infection in healthcare settings.
While FMT has proven highly effective, its lack of standardization remains a major drawback. The microbial composition of FMT varies depending on the donor, and the delivery method can impact success rates. Prescription-only microbiome treatments, known as live biotherapeutic products (LBPs), aim to address these limitations by containing defined species of beneficial bacteria. Biomictra and Rebyota, approved for preventing recurrent C. diff infections, are delivered rectally and manufactured from donor samples. Vowst, an orally administered capsule approved by the U.S. Food and Drug Administration, contains 50 species of Firmicutes bacteria spores from donors. In clinical trials, Vowst has demonstrated efficacy in reducing recurrent infections compared to a placebo. Other companies, such as Vedanta Biosciences, are developing microbiome therapies with promising results. Vedanta’s capsule, VE303, has shown an over 80% reduction in the odds of recurrence compared to placebo, and it features eight live strains of bacteria selected for their ability to resist C. diff colonization.
Despite these exciting developments, there are challenges ahead for these therapies, including their high cost. Antibiotics like vancomycin are relatively inexpensive, while Rebyota costs £7,000 and Vowst is priced at £14,000. The cost may limit widespread adoption within the National Health Service. However, these therapies open up possibilities for developing more microbiome-based treatments for other diseases, initially focusing on gut-centric conditions like inflammatory bowel diseases, with the potential to expand to other areas in the future.
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