Human gut microbes play a pivotal role in the maintenance of human health, immune response, and neurobehavioral traits. It refers to the collection of different microbes, including viruses, fungi, and bacteria, that are present in the human body. The human gastrointestinal tract harbors more than 10 trillion microbes that are responsible for immune regulation. The gut microbes also have a marked influence on the host body during homeostasis. The exploration of gut microbes has enriched scientists with exceptional knowledge of microbial colonization, dysbiosis, and other health subsets. The gut microbes have shown enormous potential in the maintenance of human health—making it a new therapeutic approach to fight against human disorders.
Considering the key significance, microbiome therapeutics emerge as a promising solution to treat different disease conditions such as autoimmune disorders, metabolic disorders, gastrointestinal disorders, and even oncological disorders. Several microbiome manufacturing companies are aiming to reengineer human gut microbes using genetic engineering and genome sequencing with an application of Bacteriophage, antibiotics, and bacteriocins. The use of microbes for therapeutics helps to personalized treatment and harmonize conventional therapeutics. Recognizing the therapeutic potential, several companies are accelerating their efforts in the development of therapeutic solutions using gut microbes. The live biotherapeutic products and microbiome manufacturing market is estimated to be worth $23 million in 2022 and is expected to grow at compounded annual growth rate (CAGR) of 20% during the forecast period.
What is Microbiome Therapeutics?
Microbiome therapeutics refers to the modifications of gut microbes either by adding gene, deleting gene or by following modulatory approaches. The modified microbes are used for therapeutic purposes to treat a wide range of diseases including gastrointestinal infection. Moreover, the microbiome therapeutics also aim to combat the challenges with traditional therapeutic drugs, such as antimicrobial resistance, and provide promising solutions for the management of human diseases.
What Are The Significances of Microbiome Therapeutics?
It is worth noting that the constant use of conventional therapeutic drugs has resulted in antibiotic resistance, poor specificity, drug non-responsiveness, and resistance to chemotherapy. Specifically, the increasing risk of antibiotic resistance has created a lot of troubles in treatment. Microbiome therapy helps to overcome the drawbacks of traditional medicines as these microbes are naturally occurring inside the body, enhancing the therapeutic efficiency without causing side effects. Here are some specific reasons why microbiome therapy is essential for treatment purposes.
▪ Microbes can be easily re-modified and engineered genetically to use for therapeutic purposes. For instance, E. coli can be genetically modified to transform into a drug carrier that possesses the capability to initiate cell lysis in targeted cells.
▪ Microbiome therapeutics help to maintain a diverse microbial community inside the gut for better nutrient absorption.
▪ Fecal matter transplants are used for the treatment of Clostridium difficile infection. It also helps to restore the bacterial diversity of the gastrointestinal tract and bacterial-derived metabolites also known metabolomes.
▪ Microbiome therapeutics play a crucial role in immune system response, potentially reducing the risk of chronic diseases such as autoimmune disorders. In addition, microbes can be genetically altered to improve the safety and efficacy of the drugs.
▪ Probiotics that are designed from live microorganisms, specifically Lactobacillus, Saccharomyces, and Bifidobacterium, helps to maintain gut health by maintaining microbiomes.
▪ Microbiome therapeutics are helpful to restore the gut microbes that are disturbed after prolonged consumption of antibiotics, eliminating risk of antibiotic-associated diarrhea.
How Can Microbiome Therapeutics Be Employed?
Several efforts have been made to harness the potential of host-microbiome interactions for the development of microbiome therapeutics. At present, there are three strategies followed to implement microbiome therapy including:
▪ Additive Therapy
It refers to the addition of microbial consortia or strains to modify it for therapeutic purposes. The microbial consortium or individual strain is administered either through fecal microbiota transplantation (FMT) or as probiotics. The microbes used in additive therapy can either be genetically engineered or naturally isolated from the human gut region to produce therapeutic molecules. For instance, fecal transplants have been used to treat Clostridium difficile infection. The pure culture has been isolated from the health donor and administered to the patient through FMT.
▪ Subtractive Therapy
Subtractive therapy is a promising approach in the field of microbiome therapeutic engineering. It aims to decrease the pathogens from the microbiome by using the antimicrobial activity of bacteriophage and bacteriocins. The approach has been used to target pathogens that cause one set of diseases without causing side effects to another microbiome. For instance, Bacteriocin 21 has been used to limit infection due to multidrug resistance Enterococcus bacteria.
▪ Modulatory Therapy
Modulatory therapy primarily involves modification and manipulation of the host-microbiome interaction by using non-living agents. The modification of the gut microbiota can be done through different modulations such as exercise, diet, and antibiotics.
Psychobiotics refers to the group of live Biotherapeutics products such as postbiotics, probiotics, prebiotics, and synbiotics. These therapeutic products initiate psychotropic effects on stress, anxiety, and depression, thereby helping patients get rid of these symptoms.. Bacterial strains such as Lactobacillus odontolyticus and Lactobacillus plantarum produce enormous amounts of acetylcholine that have shown beneficial results in the treatment of insomnia, Alzheimer’s disease, and Parkinson’s disease.
What Are The Challenges in Using Microbiome Therapeutics?
The most significant challenge faced by microbiome manufacturing companies is the individuality of the microbiome. Each microbiome possesses unique characteristics, and understanding each character is a tricky task and consumes a lot of time for the researchers. Other challenges associated with microbiome manufacturing include:
▪ Different microbial strains are needed to treat a different form of infection. The isolation of different microbial strains, specifically healthy gut microbes, is challenging for the researchers.
▪ The success of the microbiome therapeutics depends on the stability and efficacy of the microbial strain isolated from the donor. Therefore, companies have to develop the latest technologies to understand the environmental conditions, natural habitat, and mutual interaction of microbes that potentially affect their function.
▪ Various regulatory compliances have to be addressed before proceeding with clinical trials of the microbiome therapeutics.
How Researchers Overcome The Challenges For The Development of Microbiome Therapeutics?
A detailed understanding of the microbiome can help to overcome the challenges faced with traditional therapeutic drugs. Presently, several microbiome manufacturing companies have shown interest in the development of microbiome therapeutics by understanding the potential benefits in the treatment of disease. With ongoing efforts of scientists, in April 2023, SER-109 received approval from the FDA to be used as the first orally administered microbiota-based therapeutics to prevent Clostridium difficile infection. The microbiome therapeutics modulates the disrupted microbiome into a state that can resist C. difficile growth and colonization. Additionally, microbiome manufacturing companies are leveraging advanced technologies such as organ-on-a-chip models, specifically gut-on-a-chip models, and 3D technology to study the interaction of probiotics and hosts.
Future Perspective of Microbiome Manufacturing Market
Overall, the advancements in gene sequencing and genetic engineering allow scientists to explore microbiomes for therapeutic purposes. As of now, several live biotherapeutic manufacturing companies have accelerated research and development efforts using technologies such as artificial intelligence, bioinformatics, and biotechnology to prove the efficacy of microbiome therapeutics for efficient treatment. The current era of microbiome therapy, with joint efforts, can develop clinical applications for the treatment of diseases that cannot be cured with the traditional approach. It is worth highlighting that with ongoing clinical trials, we will soon see more microbiome therapeutics in the future.
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