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Rakotonirina, Adèle; Galperine, Tatiana; Audry, Maxime; Kroemer, Marie; Baliff, Aurélie; Carrez, Laurent; Sadeghipour, Farshid; Schrenzel, Jacques; Guery, Benoît; Allémann, Eric
International journal of pharmaceutics, 05/2023, Volume: 639Journal Article
Display omitted •A novel oral formulation has been developed for a complex mixture of microorganisms.•Alginate microencapsulation was successfully applied to fecal samples.•Microencapsulation of gut microbes led to high-loaded particles.•Alginate particles maintain the viability of gut microbes after lyophilization. Clostridioides difficile infection (CDI) is a critical nosocomial infection with more than 124,000 cases per year in Europe and a mortality rate of 15–17 %. The standard of care (SoC) is antibiotic treatment. Unfortunately, the relapse rate is high (∼35 %) and SoC is significantly less effective against recurrent infection (rCDI). Fecal microbiota transplantation (FMT) is a recommended treatment against rCDI from the second recurrence episode and has an efficacy of 90 %. The formulation of diluted donor stool deserves innovation because its actual administration routes deserve optimization (naso-duodenal/jejunal tubes, colonoscopy, enema or several voluminous oral capsules). Encapsulation of model bacteria strains in gel beads were first investigated. Then, the encapsulation method was applied to diluted stools. Robust spherical gel beads were obtained. The mean particle size was around 2 mm. A high loading of viable microorganisms was obtained for model strains and fecal samples. For plate-counting, values ranged from 1015 to 1017 CFU/g for single and mixed model strains, and 106 to 108 CFU/g for fecal samples. This corresponded to a viability of 30 % to 60 % as assessed by flow cytometry. This novel formulation is promising as the technology is applicable to both model strains and bacteria contained in the gut microbiota.
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