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Clinical Trials in the UK / NCT06237452
Recruiting Phase 3

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

NCT06237452 · tracked via the Priya Life Science UK tracker
Sponsor
Vedanta Biosciences, Inc.
Phase
Phase 3
Started
2024-05-20
Last updated
2026-09-14

Condition(s) studied

Clostridium DifficileClostridium Difficile InfectionsClostridium Difficile Infection RecurrenceClostridioides Difficile InfectionClostridioides Difficile Infection RecurrenceCDIC. Diff InfectionRecurrent Clostridium Difficile InfectionC.Difficile DiarrheaDiarrhea Infectious

Investigational drug(s) / intervention(s)

VE303Placebo

VE303: 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: 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 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).

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population): * Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months Key Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population): * Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI * OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors: 1. Age ≥ 65 years 2. Kidney dysfunction, defined as estimated creatinine clearance \< 60 mL/min/1.73 m\^2 at the time of the qualifying CDI episode 3. History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study 4. History of a prior CDI episode between 6 and 12 months prior to enrollment 5. Immunosuppression due to an underlying disease or its treatment 6. Has undergone solid organ or hematopoietic stem cell transplantation Key Inclusion Criteria (For enrollment in Stage 1 or 2): * The qualifying episode of CDI must meet all the following criteria: 1. New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days 2. CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI 3. Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as enzyme immunoassay (EIA) for toxin A/B and glutamate dehydrogenase (GDH) with polymerase chain reaction (PCR) reflex testing for discordant EIA/GDH results, performed at either a local laboratory or the central laboratory 4. Diarrhea considered unlikely to have another etiology * Prior to receiving any study medication, the participant should: 1. Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible for decentralized participants to be randomized during SoC antibiotic administration. 2. Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, \< 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days * Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing * Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization Key Exclusion Criteria (For both Stage 1 and Stage 2): * History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI * Known or suspected toxic megacolon or small bowel ileus at the time of randomization * History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis * Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode * Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug * Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study) * Probiotics, whether characterized as a dietary/food supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. (Note: consumption of food-based products such as yogurt, kombucha, and kefir are permitted.) * Absolute neutrophil count (ANC) of \< 0.5 ×10\^9 cells/L on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC \< 1.0 × 10\^9 cells/L

Primary outcome measure(s)

Trial sites (215)

FacilityCityRegionStatus
Metro Infectious Disease Consultants Huntsville Alabama Recruiting
Advanced Gastroenterology, P.C. Chandler Arizona Withdrawn
Mayo Clinic Hospital Phoenix Arizona Withdrawn
GI Alliance Sun City Arizona Recruiting
Om Research, LLC Apple Valley California Withdrawn
Science 37 Inc (Remote/Home option) Culver City California Recruiting
Children's Hospital of Los Angeles Los Angeles California Recruiting
VA San Diego Healthcare System San Diego California Recruiting
North America Research Institute San Dimas California Withdrawn
Clinical Trials Management Services Thousand Oaks California Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California Recruiting
Connecticut Clinical Research Institute Bristol Connecticut Recruiting
Medical Research Center of Connecticut Hamden Connecticut Recruiting
Hartford Hospital Hartford Connecticut Withdrawn
Gastro Florida Clearwater Florida Recruiting
Proactive Clinical Research, LLC Fort Lauderdale Florida Recruiting
Encore Borland-Groover Clinical Research Jacksonville Florida Recruiting
GI Pros Research Naples Florida Recruiting
Advanced Medical Research Center Port Orange Florida Recruiting
KM International Research Operation LLC Saint Cloud Florida Recruiting
James A. Haley Veterans' Hospital Tampa Florida Recruiting
International Center for Research Tampa Florida Recruiting
Summit Clinical Research, LLC Athens Georgia Recruiting
Emory University Hospital Midtown Atlanta Georgia Recruiting
Metro Infectious Disease Consultants Decatur Georgia Recruiting
Regional Infectious Diseases and Infusion Center, Inc. La Grange Georgia Withdrawn
Gastrointestinal Specialists of Georgia Marietta Georgia Recruiting
Snake River Research, PLLC Idaho Falls Idaho Recruiting
Metro Infectious Disease Consultants Burr Ridge Illinois Recruiting
NorthShore University Health System - Evanston Hospital Evanston Illinois Withdrawn
GI Alliance Gurnee Illinois Recruiting
Innovative Clinical Research Center, LLC (ICRC) Island Lake Illinois Withdrawn
Indiana University Health University Hospital Indianapolis Indiana Recruiting
Gastroenterology Health Partners New Albany Indiana Recruiting
Deaconess GI Specialty Center Newburgh Indiana Withdrawn
University of Kansas Medical Center Kansas City Kansas Recruiting
IDC Clinical Research, LLC Wichita Kansas Withdrawn
Gastroenterology Health Partners Louisville Kentucky Recruiting
Ochsner Clinic Foundation New Orleans Louisiana Recruiting
Johns Hopkins Hospital Baltimore Maryland Active Not Recruiting

+ 175 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06237452 on ClinicalTrials.gov ↗ ← All trials in the UK