Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mikrobiomik Healthcare Company S.L.
• Treatments: Fidaxomicin

Criteria

Inclusion Criteria:

1. Patients of both genders, over 18 years.

2. Patients that undergo the first, second or subsequent recurrences of CD infection, as long as they have completed at least one course of treatment with standard oral antibiotic (vancomycin) in the primary episode and which has ended at least 48 hours before the enrollment of the subject in the study.

3. Presence of an episode of diarrhea defined as ≥3 stools/24 hours.

4. Confirmation of the presence of CD toxin A and/or B in faeces, by a direct toxin detection test or by the PCR technique for the detection of A and/or B toxin producing genes, within 48 hours prior to the enrolment of the subject in the clinical trial.

Exclusion Criteria:

1. Previous faecal microbiota transfer.

2. Active inflammatory bowel disease (ulcerative colitis, Crohn's disease, or microscopic colitis).

3. Diagnosis of irritable bowel syndrome (IBS) according to Rome III criteria.

4. Transplanted patients, except those with a solid organ transplant of more than 2 years, with good organ function.

5. Absolute neutrophil count <500 cells /μL at the time of the enrollment in the study.

6. Pregnancy, breastfeeding, or pregnancy intentions over the course of the study.

7. Active treatment with bile acid sequestrants (for instance: cholestyramine).

8. Positive patients for the human immunodeficiency virus (HIV) except those with lymphocytes T CD4 count > 200 cells/μL and viral load less than 20 copies.

9. Active or refractory neoplasia.

10. Radiotherapy in the intestinal area, previous or in progress, or active chemotherapy in the last 90 days.

11. Swallowing dysfunction or no oral motor coordination.

12. Patient admitted in an intensive care unit or expected to be admitted in an intensive care unit due to serious illness and with indication of treatment with antibiotic.