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Looking for participantsPhase3

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Sponsor: Vedanta Biosciences, Inc.

NCT ID: NCT06237452

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
Mix of remote tasks and in-person visits
Drug or intervention
VE303 (biological), Placebo (biological)
How long the study runs
Study runs about 41 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
12 Years and over
Who
All
Number of participants
852
Started
2024-05-20
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for clostridium difficile
  • • Phase3 - 852 participants
  • • 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

Who can take part?

  • • Ages 12 Years and over
  • • Diagnosed with clostridium difficile

Where?

  • • Exeter - Royal Devon University Healthcare NHS Trust
  • • Bournemouth - The Royal Bournemouth Hospital
  • • Bristol - North Bristol NHS Trust - Southmead Hospital, Clinical Research Centre
  • • Edinburgh - NHS Lothian - Western General Hospital
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

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

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years and over
  • Who can join: All genders

Biomarkers mentioned

was positive

What the study is looking for

  • ✓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...
  • ✓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:
  • ✓Age ≥ 65 years
See the full criteria
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

Where Is This Study? (8 UK sites)

Royal Devon University Healthcare NHS Trust

Exeter EX2 5DW, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

The Royal Bournemouth Hospital

Bournemouth BH7 7DW, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Research Development & Support

clinicalresearch@bournemouth.ac.uk01202 961200

North Bristol NHS Trust - Southmead Hospital, Clinical Research Centre

Bristol BS10 5NB, United Kingdom

Recruiting
Site contact (verified)

NHS Lothian - Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)

Royal Free London NHS Foundation Trust

London NW3 2QG, United Kingdom

Recruiting
Site contact (verified)

St.Thomas' Hospital

London SE1 7EH, United Kingdom

Recruiting
Site contact (verified)

Northern General Hospital

Sheffield S5 7AU, United Kingdom

Recruiting
Site contact (verified)

Morriston Hospital

Swansea SA6 6NL, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Gary Connor

Sponsor contact

CONTACT

857-706-1427 Consortium02-ctinquiries@vedantabio.com

Steven Shiff, MD

Sponsor contact

CONTACT

857-706-1427 Consortium02-ctinquiries@vedantabio.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09