Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

NCT06237452 · View on ClinicalTrials.gov ↗

Study Summary

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).

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL VE303

Study Locations (20)

California

  • Om Research, LLC — Apple Valley
  • Science 37 Inc (Remote/Home option) — Culver City
  • Children's Hospital of Los Angeles — Los Angeles
  • VA San Diego Healthcare System — San Diego
  • North America Research Institute — San Dimas
  • Clinical Trials Management Services — Thousand Oaks
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance

Florida

  • Gastro Florida — Clearwater
  • Proactive Clinical Research, LLC — Fort Lauderdale
  • Encore Borland-Groover Clinical Research — Jacksonville
  • GI Pros Research — Naples
  • Advanced Medical Research Center — Port Orange
  • KM International Research Operation LLC — Saint Cloud
  • James A. Haley Veterans' Hospital — Tampa

Arizona

  • Advanced Gastroenterology, P.C. — Chandler
  • Mayo Clinic Hospital — Phoenix
  • GI Alliance — Sun City

Connecticut

  • Connecticut Clinical Research Institute — Bristol
  • Medical Research Center of Connecticut — Hamden
  • Hartford Hospital — Hartford

Trial Details

FieldValue
Enrollment Target 852 participants
Start Date 2024-05-20
Est. Completion 2027-10
Phase Phase 3

Sponsor

Vedanta Biosciences

1 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06237452

The ClinicalTrials.gov registry entry for NCT06237452 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 852 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vedanta Biosciences, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Clostridioides Difficile Infection appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06237452 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06237452 about?

NCT06237452 is a clinical study titled "VE303 for Prevention of Recurrent Clostridioides Difficile Infection". 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 ...

What is the current status of trial NCT06237452?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 852 participants. The study started on 2024-05-20. Estimated completion is 2027-10.

What conditions does trial NCT06237452 study?

This clinical trial studies the following conditions: Clostridioides Difficile Infection, Clostridium Difficile, Clostridium Difficile Infection Recurrence, CDI, Recurrent Clostridium Difficile Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06237452?

The interventions under investigation include: Placebo (BIOLOGICAL), VE303 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06237452?

This trial is sponsored by Vedanta Biosciences, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06237452 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial