Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
Patients with microbiota alterations developed after being exposed to antibiotics are
especially susceptible to Clostridioides difficile infections (CDI). The incidence and
severity of CDI has increased in recent years and CDI recurrences (r-CDI) due to the
appearance of new episodes in patients with a previous cured CDI, represent a serious and
complex clinical issue. The treatment of these recurrences is not adequately standardized,
and although the most widely used treatment is the administration of fidaxomicin and
bezlotoxumab, its efficacy in patients who already have r-CDI is not proven. In recent years,
Fecal Microbiota Transfer (FMT) has emerged as the preferred non-pharmacological treatment to
manage CDI with multiple recurrences.
The objective of this study is to assess the efficacy and safety of the MBK-01 medication,
consisting of heterologous lyophilized fecal microbiota capsules coming from healthy donors
in comparison to the treatment with Fidaxomicin, in 98 patients with r-CDI.