Human Biome S.A. has been awarded financial support within the European Funds for Smart Economy program

Project Title: Development of an advanced FMT formulation – an ecobiotic containing concentrated and preserved human gut microbiota with an extracellular matrix for enhanced stability, viability, and efficacy in the therapy of CDI infections.

The project will be implemented by a consortium consisting of Human Biome S.A. (Consortium Leader) and the Wrocław University of Environmental and Life Sciences (Consortium Member).

Tasks and Activities to be Implemented within the Project

• Task 1: Development of a standardized microbiota production process for its subsequent preservation.

• Task 2: Development of methods to assess the viability and biodiversity of the preparations—based on microbiological, molecular, and cytometric techniques.

• Task 3: Development and comparison of 4 preservation methods, followed by the selection of the most advantageous one.

• Task 4: Development of an encapsulation process for the selected FMT preparation, ensuring its stability and protecting the microorganisms against oxygen while enabling effective release in the large intestine.

• Task 5: Efficacy testing in an animal model, comparing the performance of the encapsulated preparation with a reference frozen preparation (MBiotix® HBI Caps), including clinical, physiological, and immunological assessments.

• Task 6: Stability testing of the encapsulated preparation under various storage conditions and durations, determining its stability and suitability for clinical applications.

Target Groups

The implementation of the project’s outcomes will significantly increase the availability of FMT therapy for patients infected with Clostridioides difficile by eliminating logistical, technological, and psychological barriers associated with current delivery methods (endoscopy, frozen capsules).

Project Objectives

The objective of the project is to develop an innovative, oral form of FMT (Fecal Microbiota Transplantation) therapy—an ecobiotic containing concentrated, preserved, and active human gut microbiota along with the extracellular matrix (ECM), intended for use in the treatment of Clostridioides difficile infections.

Project Outputs and Outcomes

The outcome of the project will be a stable capsule formulation that can be stored at +5°C +/- 3°C for at least 6 months, while maintaining bacterial viability of ≥45%. It eliminates the need for freezing, offers high therapeutic potential (biodiversity, engraftment), requires a limited number of capsules per single dose (<35), and features the unique presence of the extracellular matrix.

There is currently no commercial FMT preparation with similar properties available worldwide, which gives this project the character of a breakthrough innovation.

Financial Breakdown

Category	Amount
Total Project Value	34,330,336.90 PLN
European Funds Contribution	24,104,174.81 PLN