RecruitingPHASE3INTERVENTIONAL

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

This research, called RESTORATiVE303, is looking into a new medicine called VE303. The main goal is to see if VE303 can help prevent repeated Clostridioides difficile (C. diff) infections, which cause severe diarrhoea. Participants will either receive VE303 or a dummy pill (placebo) for 14 days. Researchers will then check if the C. diff infection comes back within 8 weeks and monitor for any side effects. This study is for people who have had C. diff before or are at high risk of getting it for the first time. We want to understand if VE303 is a safe and effective way to reduce the chance of this unpleasant infection returning.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Vedanta Biosciences, Inc.

Enrolment target

852

Start

20 May 2024

Estimated completion

01 Oct 2027

Clostridium Difficile Clostridium Difficile Infections Clostridium Difficile Infection Recurrence Clostridioides Difficile Infection Clostridioides Difficile Infection Recurrence CDI C. Diff Infection Recurrent Clostridium Difficile Infection C.Difficile Diarrhea Diarrhea Infectious

What is this study about?

This study is investigating a new medication called VE303. The main aim is to find out if VE303 can help stop Clostridioides difficile (often called C. diff) infections from returning. C. diff is a type of germ that can cause severe diarrhoea and other gut problems, especially after taking antibiotics. For many people, C. diff can keep coming back, which is very difficult to deal with.

Participants in this study will receive either the new medicine, VE303, or a 'placebo', which looks exactly the same but contains no active medicine. This is a common way to test new treatments fairly. You won't know whether you're getting VE303 or the placebo. The study will last for 14 days, during which you'll take the medicine. After that, the researchers will closely watch to see if the C. diff infection comes back within 8 weeks and how you're feeling overall.

This research is really important because if VE303 is successful, it could offer a new way to prevent this challenging infection from recurring, improving the lives of many people who suffer from repeated C. diff. They will also be checking carefully for any unwanted effects (side effects) of the new medicine.

Key takeaways

The study tests a new medicine (VE303) to prevent C. diff from returning.
Participants will get either VE303 or a dummy pill (placebo) for 14 days.
Researchers will check if C. diff comes back within 8 weeks.
It's for people who've had C. diff before or are at high risk.
Close medical care and supervision will be provided during the study.

Who may be eligible?

This study is looking for people who currently have C. diff and fit certain criteria. You might be able to join if you are aged 12 or over and have had C. diff before within the last six months. This is for people whose C. diff has returned.

Alternatively, if this is your first time getting C. diff but you have certain risk factors, you might also be eligible. For example, if you are 75 or older, or if you are 12 or older and have at least two other risk factors such as being 65 or older, having kidney issues, regularly taking certain stomach acid medicines, or having a weakened immune system.

Regardless of which group you fit into, your C. diff diagnosis must be confirmed by a lab test, and your diarrhoea must have started recently and be severe enough. You must also have finished or be close to finishing your usual antibiotic treatment for C. diff before starting the study medicine.

Quick self-check

Are you 12 years old or older?
Have you been diagnosed with C. diff?
If you've had C. diff before, was it within the last 6 months?
If this is your first C. diff, are you 75 or older, or do you have at least two specific risk factors?
Have you started or nearly finished your usual C. diff antibiotic treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, you'll first have some checks to make sure you're suitable. Once enrolled, you will receive either the study medicine (VE303) or a placebo (a dummy pill) for 14 days. You will need to take this medicine as instructed. During this time and for 8 weeks afterwards, you will have regular check-ups with the study team. These visits will involve answering questions about your health and having some tests, such as stool samples and possibly blood tests, to see how you're doing and if the C. diff has returned. The study team will need to ensure your C. diff symptoms fit specific patterns and that your stool tests confirm the infection. You will also need to have completed your standard C. diff antibiotic treatment before starting the study medicine.

Potential risks and benefits

Taking part in a study like this might have potential benefits. You could receive a new medicine that might help prevent your C. diff infection from coming back, and you'll receive close medical care and monitoring. However, there are also potential risks, as with any medicine; VE303 might have side effects, and it might not work for everyone. There is also the possibility you receive the placebo. You are free to stop participating in the study at any time and for any reason, without it affecting your usual medical care.

Locations (215)

Metro Infectious Disease Consultants
Huntsville, United States· Recruiting
Advanced Gastroenterology, P.C.
Chandler, United States· Withdrawn
Mayo Clinic Hospital
Phoenix, United States· Withdrawn
GI Alliance
Sun City, United States· Recruiting
Om Research, LLC
Apple Valley, United States· Withdrawn
Science 37 Inc (Remote/Home option)
Culver City, United States· Recruiting
Children's Hospital of Los Angeles
Los Angeles, United States· Recruiting
VA San Diego Healthcare System
San Diego, United States· Recruiting
North America Research Institute
San Dimas, United States· Withdrawn
Clinical Trials Management Services
Thousand Oaks, United States· Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, United States· Recruiting
Connecticut Clinical Research Institute
Bristol, United States· Recruiting

+203 more sites — see the official record for the full list.

Common questions

What is C. diff?

C. diff is a type of germ that causes severe diarrhoea and other gut problems, especially after you've taken antibiotics.

What is VE303?

VE303 is a new medicine being tested to see if it can help stop C. diff infections from coming back.

What is a placebo?

A placebo is a dummy pill that looks exactly like the study medicine but contains no active ingredients. It helps researchers fairly compare the new medicine.

How long will I take the study medicine?

You will take the study medicine or placebo for 14 days.

Will I know if I'm getting VE303 or the placebo?

No, you won't know whether you're receiving VE303 or the placebo. This helps make the study as fair as possible.

How to find out more

Gary Connor

Consortium02-ctinquiries@vedantabio.com 857-706-1427 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.