A04.7
Conditions
Interventions
Group 1: Patients: 26 patients with rCDI after fidaxomicin therapy take the probiotic (MicroPlus GRCU) with Bacillus subtilis LIFEINU™ BSCU1 for 30 days
Group 2: Patients: 12 patients with rCDI after
Sponsors
Universitätsklinikum Frankfurt
Eligibility
Sex/Gender
All
Age
18 Years to 84 Years
Inclusion criteria
Inclusion criteria: Patients: 1. Age = 18 years 2. Patient has had a first episode of CDI* and at least one recurrence 3. Patient is scheduled for or currently taking Fidaxomicin, but treatment will be finished upon study entry 4. Written informed consent provided prior to inclusion Healthy subjects: 1. Age = 18 years 2. Written informed consent provided prior to inclusion 3. Healthy participant, as determined by screening assessment and Principal Investigator's judgment
Exclusion criteria
Exclusion criteria: Patients: 1. Patient with any social or logistical condition, which in the opinion of the investigator may interfere with the conduct of the study, such as incapacity to well understand, not willing to collaborate, or cannot easily be contacted for follow-up assessments 2. Planned fecal microbiota transfer (FMT) at inclusion into the study 3. Patient with a high risk for antibiotic treatment at study inclusion (except for Fidaxomicin) 4. Severely immunocompromised patients, defined as: a. Current or foreseeable neutropenia within the next 14d, defined as 3 weeks f. Treatment with other recognized T-cell immunosuppressants, such as cyclosporine, TNF-alpha blockers, specific monoclonal antibodies (e.g. alemtuzumab), MTX or nucleoside analogues during the last 90 days g. Inherited severe immunodeficiency (e.g.chronic granuloumatous disease or severe combined immunodeficiency) 5. Patient requiring intensive care treatment at inclusion 6. Patient has one of the following comorbidities: inflammatory bowel disease (ulcerative colitis or Crohn’s disease), irritable bowel syndrome 7. Prolonged Fidaxomicin therapy immediately prior to inclusion (> 28 days) 8. Patient is allergic to one of the study treatment components: glycerin, gelatin, sunflower lecithin Healthy subjects: 1. Participant has a significant history or manifestation of any metabolic, immunological, neurological, cardiovascular, gastrointestinal or other relevant disorder 2. Participant has any kind of chronic disease 3. Expected or frequent changes in standard medication (contraceptives, thyroid hormones and similar hormonal substitution is allowed, when verified by the Investigator or designee) 4. Participant is allergic to one of the study treatment components: glycerin, gelatin, inulin, sunflower lecithin, citric acid, pyridoxine hydrochloride, orange oil, cyanocobalamin, steviol glycosides
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the extent of changes in the microbiota composition of study participants following a 30-days probiotic intervention using 16S rRNA and fungal ITS next-generation sequencing (NGS) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Assessment of short- and long-term changes of bacterial community patterns during and after 30 days of probiotic intervention • Assessment of short- and long-term changes of fungal community patterns during and after 30 days of probiotic intervention • Assessment of short- and long-term changes in patient-reported gastrointestinal health-related quality of life during and after 30 days of probiotic intervention • Assessment of differences regarding gastrointestinal symptoms in rCDI patients receiving the probiotic compared to those receiving placebo via stool and symptom diaries • Assessment of potential changes of the gut microbiota composition in healthy subjects during and after 30 days of probiotic intervention • Assessment of potential changes in self-reported gastrointestinal symptoms during probiotic intervention in healthy study participants • Assessment of the potential influence of Steviol glycosides as natural sweetening additive on the probiotic effects of B. subtilis LIFEINU™ BSCU1 on the gut microbiota composition in healthy subjects | — |
Countries
Germany
Contacts
Public ContactMaria J.G.T. Vehreschild
Universitätsklinikum Frankfurt
Outcome results
None listed