The landscape of healthcare is being reshaped by the revolutionary progress of Microbiome Therapeutics, exerting substantial influence on the industry, globally. In a recent interview, Dr Ashley Naidoo, Director of Natmed Solutions, shared insights with Muhammad Younis regarding the implications of these novel developments for South Africa's health sector.

#LBS: Microbiome therapeutics is a rapidly evolving field. Can you provide an overview of what microbiome therapeutics entails and how it differs from traditional treatments?

Dr Ashley: Microbiome therapeutics is an emerging field involving small molecules, antimicrobial peptides and even implantation of live microbiota to influence changes in taxonomy or function of the microbiome for effect locally and at distant sites.

There are 4 major areas of focus for these agents viz:

• Prebiotics which are mainly fibres and nutritive substances that the microbes ferment and are not digestible by human enzymatic processes.
• Probiotics which are live microorganisms that are ingested or applied to influence microbial communities.
• Postbiotics are microbial fermentation products or non-viable microbe components that are readily absorbed and influence function at epithelial barrier sites.
• Faecal Microbiota Transplantation involves transplanting a microbial community from a “healthy” individual to another individual under strict conditions and currently only approved for treatment of Clostridium Difficile Infections.

Microbiome therapeutics is a totally different ethos to health, disease management and prevention by virtue of its approach to influencing change at microbial community level as opposed to traditional pharmacological approaches based around host processes.

#LBS: Presently, what types of microbiome therapeutics are available or in development for gut health issues? Are these treatments accessible to the general public or limited to specific conditions or populations, particularly in South Africa?

Dr Ashley: Microbiome therapeutics is a fairly new and barely regulated by the South African Health Products Regulatory Authority. At the moment our market has had a boom in fermented foods viz Kefir and Kombucha and probiotics specifically Lactobacillus and Bacteroides Sp. derived. As a country with a large divide between public funded healthcare services devoid of microbial therapeutics and the private and consumer sector where the major spend on such is occurring, the reach is mostly limited to the private sector at this setting.

At Natmed Solutions, a specialist clinician owned and managed entity in the South African Private Healthcare and Biotechnology landscape, we are currently exploring precision probiotics and postbiotics to influence specific non-communicable disease processes from a preventative medicine perspective. Our areas of focus spans total body microbiome influence, but for gut health specifically we are currently exploring precision probiotics for medical weight loss and postbiotic applications for IBS and IBD.

#LBS: What are the most promising and innovative microbiome therapeutics currently undergoing clinical trials? What would it mean if the trials are successful?

Dr Ashley: Currently the most innovative microbiome therapeutics stem from the Northern Hemisphere as Africa, being the least studied host and microbiome genomic continent is on a journey to first define enterotypes specific to our people. That being said, interplay between ourselves being clinicians and scientists in the Northern Hemisphere is ongoing to find solutions to our population.

The most interesting of these interventions undergoing clinical trials are the field of psychobiotics utilising gut microbiome therapeutics to influence the gut-brain axis via HPA Axis, Neurotransmitter production and immunomodulation in conditions like Parkinsonism, Stress, Anxiety and Depression. Other interesting ongoing trials include probiotic based gut microbiome programming in preterm babies to influence infantile colic.

These interventions if successful can revolutionise the pharmacological market as we know it. Firstly it takes into account pharmacomicrobiomics and a natural approach to disease prevention and management but also takes us a step closer to precision and personalised medicine as research to affect microbial communities first involves microbiome sampling and testing. This approach will yield large data sources, hopefully from populations around the world, to better create pharmacological agents taking all genomic and microbial makeups into account.

#LBS: Could you describe the general process of conducting clinical trials for microbiome therapeutics? What are the key challenges and considerations unique to this area of research?

Dr Ashley: The process of clinical trials with microbiome therapeutics follows a similar process with other novel pharmacological agents and using Good Clinical Practice (GCP) and ethical guidelines. These involve first safety profiling, some animal test studies and thereafter human studies followed by efficacy testing (the most challenging part). What differs the most is the regulations and consensus on these research outcomes. Currently consensus on first defining what a healthy microbiome state individualised to patient groups, population groups and environments is, is lacking. This area is where the major challenge is. Secondly, Next Generation Sequencing technologies deployed to monitor microbial communities and their metabolic functions are not an exact science and subject to some scrutiny in relevance. As the majority of products derived in this space blend into more the nutraceutical space regulations on definitions, claims and dispensing are also being sought.

#LBS: In your opinion, what role does personalized medicine and microbiome profiling play in tailoring microbiome therapeutics to meet the unique needs of individual patients? Are there any limitations or ethical considerations to be mindful of in this approach?

Dr Ashley: Personalised medicine is the target of most therapeutic approaches in the near future. Genomics based diagnostics and therapies were the big driving force behind it but one cannot change their genetic predisposition to a disease, but more likely alter other predisposing risk factors to reduce likelihood of expression. This is where microbiome based care is different, we can sample an individual’s microbiome and change can be effected to that community to reprogramme if you must the landscape and function of that organ. Limitations are the high cost of such interventions with shotgun metagenomics, long read sampling and metabolomics being needed to make accurate predictions towards sourcing microbiome based biomarkers and drive microbiome based therapeutics. Ethically I would say the lack of funding for such research in poorer continents is where the problem lies. A simple cut and paste of what works in the Northern Hemisphere is not possible for us in Africa. We need greater projects to support broader scale microbiome care objectives and derive therapeutics that are bespoke to our communities.

#LBS: How important do you think events like the London Biotechnology Show are in mainstreaming biotech solutions like microbiome therapeutics in the world?

Dr Ashley: Showcasing biotechnology to the world is an extremely important thing. It was Steve Jobs that was famously quoted for saying the biggest innovations of the 21st century would be at the intersection of biology and technology. Showcasing the intersection of microbiome ecology in marine biology, soil ecology and agriculture, livestock microbiomes and human health as an all-encompassing layering of cause and effect….Now that’s a show I believe would change the world.