The purpose of the study is to learn more about whether a medication called VE303; which is being developed by Vedanta Biosciences Inc; is safe and effective in preventing recurring Clostridioides difficile Infection (CDI). VE303 contains 8 strains of live bacteria, found in the intestines of healthy people and when taken orally for 14 consecutive days, aims to prevent recurring CDI. CDI is one of the most common healthcare-associated infections. Once a patient suffers a CDI recurrence, the likelihood of a second is approximately 40%, increasing thereafter. Additionally, the proportion of patients who respond to treatment declines with multiple recurrences.

The main objective is to compare the CDI recurrence rate at Week 8 in participants treated with VE303 versus placebo. The secondary objectives are to compare the safety profile of the drug, the recurrence of CDI at weeks 12 and 24 and also the effects on health-related quality of life and CDI symptoms.
420 Participants will be enrolled into Stage 1 (rDCI) and 432 participants will be enrolled into Stage2 (pCDI) across 22 countries, with approximately 11 sites in the UK.

This is a randomized, double-blind trial and so the study doctor and researchers won’t know if a participant is receiving VE303 or placebo. Participants who take part in this study will be randomized 2:1 with a 2/3 chance of receiving the study drug versus a 1/3 chance of receiving the placebo.

Initially there is a screening period of 10 to 21 days, where antibiotics are taken for the CDI episode. Thereafter, participants will receive 14-days of VE303 or placebo capsules. Participation in the study will last approximately 6.5 months.

Study participants who experience an on-study CDI recurrence may be offered the option to receive 14 days of open-label VE303, with safety follow-up through Week 24, offering the opportunity for participants initially treated with the placebo to receive VE303.

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