A phase III clinical trial in patients with recurrent Clostridioides difficile (CD) infection, to evaluate the treatment with capsules of lyophilised faecal microbiota vs fidaxomici
- Conditions
- Recurrent Clostridioides difficile (CD) infectionMedDRA version: 20.1Level: LLTClassification code 10053021Term: Gram-positive bacterial infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2020-004591-17-ES
- Lead Sponsor
- Mikrobiomik Healthcare Company S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 98
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method