A Phase 3 interventional study of VE303 and Placebo in Clostridium Difficile, Clostridium Difficile Infections and Clostridium Difficile Infection Recurrence, sponsored by Vedanta Biosciences, Inc.. Recruiting at 215 sites in 24 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Vedanta Biosciences, Inc. · Phase 3, Interventional, and Prevention
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).
251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
This study's planned enrollment of 852 is above the median of 64 across 185 interventional studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →Vedanta Biosciences, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population):
Key Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population):
OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors:
Key Inclusion Criteria (For enrollment in Stage 1 or 2):
The qualifying episode of CDI must meet all the following criteria:
Prior to receiving any study medication, the participant should:
Key Exclusion Criteria (For both Stage 1 and Stage 2):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects assigned to the VE303 arm will take 3 capsules containing VE303 per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.
Biological: VE303
Subjects assigned to the placebo arm will take 3 placebo capsules per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.
Biological: Placebo
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 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.
CDI Recurrence Rate at Week 8
Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.
Time frame: 8 weeks
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Showing the first 100 of 215 sites across 24 countries. Choose a country and city above to see the rest.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Clostridia Strain Formulation VE303
Vedanta Biosciences, Inc.