The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months
Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI
Age ≥ 65 years
Kidney dysfunction, defined as estimated creatinine clearance < 60 mL/min/1.73 m² at the time of the qualifying CDI episode
History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI
Known or suspected toxic megacolon or small bowel ileus at the time of randomization
History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis
Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode
Parallel
VE303
Biological/VaccineVE303 is a live biotherapeutic product (LBP) consisting of 8 clonally derived, nonpathogenic, nontoxigenic, commensal bacteria strains manufactured under Good Manufacturing Practices (GMP) conditions.
Placebo
Biological/VaccinePlacebo capsules contain microcrystalline cellulose. Placebo capsules are visually identical to and not discernible from VE303 capsules. Placebo capsules will not contain any VE303 drug product.
CDI Recurrence Rate at Week 8
Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.
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