CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 79 enrolled
Drug / intervention
VE303 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03788434
NCT03788434Phase 2Completed
CompareCT.gov

CONSORTIUM - A Double-Blind Placebo-Controlled Phase 2 Study of VE303 for Prevention of Recurrent Clostridium (Clostridioides) Difficile Infection

Vedanta Biosciences, Inc.·interventional·Posted Dec 27, 2018·Updated Jul 3, 2023

In Brief

A Phase 2 clinical trial evaluating VE303 and Placebo for Clostridium Difficile Infection Recurrence and 6 related conditions. Completed, enrolled 79 participants across 37 sites in 2 countries.

Detailed Summary

This study evaluated the safety and efficacy of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile Infection Recurrence, Clostridium Difficile Infection, Clostridium Difficile, Clostridioides Difficile Infection Recurrence, Clostridioides Difficile Infection, Clostridioides Difficile, CDI
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 27, 2018
Enrollment StartFeb 8, 2019
Primary CompletionJun 2, 2021
Study CompletionSep 15, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.5 years ago

Interventions

VE303drug

VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under Good Manufacturing Practices (GMP) conditions.

Placebodrug

Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules. Placebo capsules did not contain any VE303 Drug Product.