VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Conditions

• C. Diff Infection
• C.Difficile Diarrhea
• CDI
• Clostridioides Difficile Infection
• Clostridioides Difficile Infection Recurrence
• Clostridium Difficile
• Clostridium Difficile Infection Recurrence
• Clostridium Difficile Infections
• Diarrhea Infectious
• Recurrent Clostridium Difficile Infection

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• VE303 — BIOLOGICAL
  VE303 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
  Placebo 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.

Study Details

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).

Key Dates

First listed

Feb 1, 2024

Start date

May 20, 2024

Status verified

Oct 2025

Primary completion

Jun 30, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

852 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: VE303
  Subjects assigned to the VE303 arm will take 3 capsules containing VE303 per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.
• Placebo Comparator: Placebo
  Subjects assigned to the placebo arm will take 3 placebo capsules per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.

Primary Outcome Measure

CDI Recurrence Rate at Week 8 [ Time Frame: 8 weeks ]

Central Contacts

• Gary Connor
  857-706-1427
  [email protected]
• Steven Shiff, MD
  857-706-1427
  [email protected]

Locations (84)

Find similar trials in Huntsville, AL

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