Clinical Trials Logo

Clinical Trial 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.

Clinical Trial Description

This is a Phase III, multicenter, controlled and open label clinical trial in which patients who suffered at least one recurrence of CD infection after the primary episode and have completed at least one course of antibiotic treatment with vancomycin will be randomly assigned (1:1) to one of the following arms: - Dificlir (Fidaxomicina) - MBK-01 (heterologous lyophilized fecal microbiota) Objective: To assess the efficacy of FMT with capsules of lyophilized fecal microbiota (MBK-01), compared to the control (fidaxomicin) at 8 weeks after treatment. To assess the safety of MBK-01 and the quality of life of patients participating in the study. Follow up: participants will return for clinic visits at week 1, week 4 and week 8 post-treatment, and will receive follow-up phone calls at month 3 and month 6 post-treatment. Stool samples will be collected from participants for further studies at time 0 and week 8 post-treatment. Study Outcomes are detailed in the specific section of this website. Rationale: The transferred microbiota restores the recipient's intestinal microbiota by reintroducing bacterial taxa that were absent or in low proportion in the recipient before the FMT, supporting the expansion of the recipient's own commensal microbiota and re-establishing a microbiota community with a high biodiversity. Donors: All donors are screened to ensure they meet the strict requirements necessary to maintain the safety of the MBK-01. Justification: The treatment of Clostridioides difficile infections (CDI) with antibiotics is usually effective for acute symptoms, but after the initial treatment, the probability of recurrence at 8 weeks ranges from 10-20 % of cases, and once a patient has a recurrence, the probability of further recurrences increases up to 40-65 %. In recent years, Fecal Microbiota Transfer (FMT) has emerged as the preferred non-pharmacological treatment to manage CDI with multiple recurrences. The treatment of recurrences is not adequately standardized. In recent years, although the most widely used alternatives have been fidaxomicin and bezlotoxumab, their efficacy in patients who already suffer from r-CDI is not proven. The administration of the FMT through oral capsules, although it is not standardized, has proven to be effective in the restoration of intestinal microbiota of patients with r-CDI. In addition, the use of lyophilized formulas facilitates the concentration of bacteria and further optimizes the donors' sample and reduces the amount of capsules that the patient has to ingest. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05201079
Study type Interventional
Source Mikrobiomik Healthcare Company S.L.
Contact Dolores Pérez
Phone +34 608 505 507
Email [email protected]
Status Recruiting
Phase Phase 3
Start date October 29, 2021
Completion date September 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04000555 - Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI) Phase 4
Terminated NCT03065374 - Treatment for Clostridium-difficile Infection With IMM529 Phase 1/Phase 2
Completed NCT03110133 - Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff Phase 2
Recruiting NCT03617445 - Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients Phase 2
Recruiting NCT03880539 - Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection Phase 4
Not yet recruiting NCT04415918 - Bezlotoxumab Efficacy and Tolerability in Cancer Patient Phase 4
Recruiting NCT03562741 - Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile N/A
Completed NCT03788434 - Phase 2 Study of VE303 for Prevention of Recurrent Clostridium Difficile Infection Phase 2
Active, not recruiting NCT04891965 - A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI) Phase 1
Enrolling by invitation NCT04317963 - Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection
Recruiting NCT05304715 - Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection Phase 2