Clostridioides difficile infection.
Conditions
Brief summary
Proportion of participants with laboratory confirmed CDI recurrence through Week 8
Detailed description
Incidence and severity of treatment-emergent adverse events (TEAEs), treatment-related TEAEs, serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) through week 8 and 24, Proportion of participants with laboratory confirmed CDI recurrence through Week 12 and Week 24, Fecal VE303 bacterial strain colonization abundance and duration, Change from baseline in the Cdiff32 score Change from baseline in EQ-5D score, utility index, and EQ VAS score Change from baseline in CDI-DaySyms daily symptoms score, Relationship between of VE303 strain colonization and CDI recurrence rate and time to recurrence.
Interventions
DRUGPlacebo capsules containing microcrystalline cellulose
DRUGvisually identical to and not discernible from VE303 capsules. Placebo capsules do not contain any bacterial strains or formulation buffer used in the VE303 drug product.
Sponsors
Vedanta Biosciences Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with laboratory confirmed CDI recurrence through Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs), treatment-related TEAEs, serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) through week 8 and 24, Proportion of participants with laboratory confirmed CDI recurrence through Week 12 and Week 24, Fecal VE303 bacterial strain colonization abundance and duration, Change from baseline in the Cdiff32 score Change from baseline in EQ-5D score, utility index, and EQ VAS score Change from baseline in CDI-DaySyms daily symptoms score, Relationship between of VE303 strain colonization and CDI recurrence rate and time to recurrence. | — |
Countries
Belgium, Bulgaria, Czechia, Denmark, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Spain
Outcome results
None listed