A randomised, controlled, open-label phase III clinical trial in patients with recurrent Clostridioides difficile (CD) infection, to evaluate the efficacy and safety of capsules of lyophilised faecal microbiota vs fidaxomicin

Mikrobiomik Healthcare Company S.L.0 个研究点目标入组 98 人开始时间: 2020年11月11日最近更新: 2024年1月8日

适应症

试验速览

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•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. Confirmation of the presence of CD toxin A in faeces, by a direct toxin detection test or by the PCR technique for the detection of toxin producing genes, within 48 hours prior to the enrolment of the subject in the clinical trial.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 32
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 66

•1. Previous faecal microbiota transfer.
•2. History of inflammatory bowel disease (ulcerative colitis, Crohn’s disease, or microscopic colitis).
•3. Diagnosis of irritable bowel syndrome (IBS) according to Rome III criteria.
•4. Compromised immune system: immunosuppressed due to a medical condition or medicine in the last 5 years; current or recent (less than 90 days) chemotherapy treatment.
•5. Absolute neutrophil count <1.000 cells /µL at the time of the enrolment in the study.
•6. Pregnancy, breastfeeding, or pregnancy intentions over the course of the study.
•7. Use of bile acid sequestrants (for instance: cholestyramine).
•8. Use of proton-pump inhibitors (PPIs).
•9. Human immunodeficiency virus (HIV).
•10. Current radiotherapy or in the last 5 years.
•11. History of cancer in the last 5 years.
•12. Swallowing dysfunction or no oral motor coordination.
•13. Admission or expected admission in an intensive care unit for medical reasons, for a treatment with antibiotics.

发起方

Mikrobiomik Healthcare Company S.L.