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Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection

NCT03788434 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2023-07-03

Study results available
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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).

Conditions

  • Clostridium Difficile Infection Recurrence
  • Clostridium Difficile Infection
  • Clostridium Difficile
  • Clostridioides Difficile Infection Recurrence
  • Clostridioides Difficile Infection
  • Clostridioides Difficile
  • CDI

Interventions

DRUG

VE303

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Vedanta Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Darrell Pardi, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-08
Primary Completion
2021-06-02
Completion
2021-09-15
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03788434 on ClinicalTrials.gov