Recurrent Clostridioides difficile (CD) infection MedDRA version: 20.1 Level: LLT Classification code 10053021 Term: Gram-positive bacterial infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: MBK-01
Pharmaceutical Form: Capsule
INN or Proposed INN: ALLOGENEIC FAECAL MICROBIOTA, POOLED
Other descriptive name: ALLOGENEIC FAECAL MICROBIOTA, POOLED
Concentration unit: billion org
Sponsors
Mikrobiomik Healthcare Company S.L.
Eligibility
Sex/Gender
All
Inclusion 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. 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of the study is to evaluate the efficacy of the investigational medicinal product (MBK-01) compared to the control medication (fidaxomicin), 8 weeks after the treatment completion.;Secondary Objective: Secondary purposes entail evaluating the safety of the investigational medicinal product and the quality of life for patients participating in the study.;Primary end point(s): Absence of diarrhea: Number of episodes of diarrhea (3 or more stools/24 hours);Timepoint(s) of evaluation of this end point: Time 0, 1 week, 4 weeks, 8 weeks, 3 months, and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Duration of hospitalisation: time, in days, that the patient remains in the hospital, from the moment the informed consent is signed until they are discharged after receiving the investigational medicinal product - Good/bad progress of the patient. A bad progress of the patient is defined as the appearance of complications requiring an admission in an ICU - Time to recurrence/relapse depending on ramdomisation groups - Duration of treatment (days) - Overall survival: percentage of patients that are still alive after a defined period of time from the beginning of the treatment - Number of Adverse Events per ramdomisation group - Type of Adverse Events per ramdomisation group - Number of Serious Adverse Events per ramdomisation group - Type of Serious Adverse Events per ramdomisation group - Adverse Events related to the treatment - Adverse Event Seriousness - Adverse Events related to the CDI - Mortality associated with CDI - Intensive Care Unit admissions (ICU) - Adverse Events of special interest - SF36 questionnaire to evaluate the quality of life;Timepoint(s) of evaluation of this end point: - From time 0 until the patient is discharged - From time 0 to the end of the study - From time 0 to the end of the study - From time 0 to the treatment completion - From time 0 to the end of the study - From time 0 to the end of the study - From time 0 to the end of the study - From time 0 to the end of the study - From time 0 to the end of the study - From time 0 to the end of the study - From time 0 to the end of the study - From time 0 to the end of the study - From time 0 to the end of the study - From time 0 to the end of the study - From time 0 to the end of the study - Time 0, 8 weeks, and 6 months | — |
Countries
Spain
Contacts
Public ContactSTART UP UNIT
SERMES PLANIFICACION S.L
Outcome results
None listed