Stability of structure and function of lyophilized gastro-resistant formulation for fecal microbiota transplantation compared to capsules and fresh stools

Fecal Microbiota Transplantation (FMT) stands as the benchmark treatment for recurrent Clostridioides difficile infection, boasting an efficacy rate of 90%. Nevertheless, the current standard-of-care formulation, FMT in oral capsules, is susceptible to optimization. Limited research has assessed the bacterial load, viability, or composition of the microbiota in FMT, as well as its stability during storage. In collaboration with the Geneva Pharmacy laboratory (led by Professor E. Alleman), we have developed a new formulation using alginate beads. Our preliminary results indicate that the novel alginate formulation is comparable to oral capsules in terms of the Chao1 index, Shannon index, or Bray-Curtis distance. Additionally, the composition and viability of the frozen alginate particles remained stable over a 12 months evaluation. This novel formulation holds promise as it not only compares favorably to FMT oral capsules but is also more easily consumable and requires less volume. It has the potential to revolutionize FMT treatment accessibility for various indications.

Specific objectives:

• Develop a gastro-resistant formulation of alginate beads
• Ensure the stability of the obtained material over a 24 months period in both frozen and room temperature preservation
• Characterize the group of healthy volunteers for control in the current studies performed in other cohorts of the NCCR
• Initiate a pilot trial in human to test tolerance and efficacy of this new gastro-resistant lyophilized formulation.

• Dr Adele Rakotonirina,HUG Geneva  Glatt pharmaceutical Services
• Pr Eric Allémann, HUG, Geneva
• Carmen Chen, PhD student
• Pr Claire Bertelli, IMUL, Lausanne
• Pr Benoit Guery, CHUV, Lausanne
• Pr Farshid Sadeghipour, CHUV, Lausanne