Human Biome S.A. and Wrocław University of Environmental and Life Sciences are running a project to develop an oral FMT therapy in the form of an ecobiotic containing concentrated and preserved human gut microbiota together with an extracellular matrix. The project is being carried out under the European Funds for a Modern Economy programme. The aim is to prepare a product intended to treat Clostridioides difficile infections.
The work plan includes standardising the microbiota production process through to preservation and developing methods to assess viability and biodiversity using microbiological, molecular and cytometric techniques. The project includes comparing four preservation methods and selecting the most suitable one. It also includes developing an encapsulation process intended to protect microorganisms from oxygen and enable effective release in the large intestine.
The plan assumes efficacy testing in an animal model, including a comparison of the encapsulated product with a reference frozen preparation. The project documentation sets outcome requirements, including storage at around 5°C for at least six months without freezing and a minimum bacterial viability level of 45%.