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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (8 UK sites)
Royal Devon University Healthcare NHS Trust
Exeter EX2 5DW, United Kingdom
The Royal Bournemouth Hospital
Bournemouth BH7 7DW, United Kingdom
Research Development & Support
clinicalresearch@bournemouth.ac.uk01202 961200North Bristol NHS Trust - Southmead Hospital, Clinical Research Centre
Bristol BS10 5NB, United Kingdom
NHS Lothian - Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Royal Free London NHS Foundation Trust
London NW3 2QG, United Kingdom
St.Thomas' Hospital
London SE1 7EH, United Kingdom
Northern General Hospital
Sheffield S5 7AU, United Kingdom
Morriston Hospital
Swansea SA6 6NL, United Kingdom
How to Get in Touch
Gary Connor
Sponsor contactCONTACT
Steven Shiff, MD
Sponsor contactCONTACT
