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GET YOUR GUT BACTERIA IN SYNC

The RESTORATiVE303 Study is a clinical research study that is exploring an investigational drug to restore the microbiome (the bacteria that live in your gut) in people with recurrent Clostridioides difficile infection (CDI).

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Who can take part?

The study will be conducted at multiple study centers in a number of countries worldwide. We are currently recruiting for our Scarborough, Ontario location at 3030 Lawrence Ave E Suite 505 Scarborough ON M1P 2T7

We are looking for people who:

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Are at least 12 years of age and who are currently experiencing an episode of CDI.

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Have had at least 1 previous CDI episode (before the current one) within the last 6 months.

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CDI is an infection of the large bowel (a part of the digestive system) caused by the bacteria Clostridioides difficile. Symptoms include diarrhea, stomach pain, nausea, vomiting, fever, and weight loss.  

*There are other criteria that must be met to join this study. 

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Participation in The RESTORATiVE303 Study

Participation in the study lasts around 6.5 months, during which there are a total of 11 study visits (7 at the study center and 4 virtually). The study is made up of the following parts:

  • Screening (up to 4 weeks)

    The study team will determine if the patient is able to participate. During this time, the patient will receive and sign their Informed Consent Form describing the study and potential risks.

  • Study treatment (2 weeks)

    Participants are randomly assigned a study drug, either VE303 or placebo, and will have further medical tests and assessments at the study center.

  • Safety follow-up (22 weeks)

    The study center will do additional medical tests and assessments to check for any unexpected reactions to the study drug and to look for any CDI episodes since joining the study.

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About Clinical
Research Studies

Clinical research studies are conducted to find out whether an investigational drug is safe and effective in treating a disease or preventing certain conditions. “Investigational” means that the drug has not been approved by a country’s regulatory authority for a particular clinical use and is still being evaluated in clinical research studies such as the one described in this guide. Clinical research studies also check for any side effects that may develop while taking the investigational drug.

Clinical research studies are performed according to strict governmental and ethical guidelines. These guidelines help to ensure that participants’ rights are protected while information about the investigational drug is collected.

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What are the phases of clinical research?

An investigational drug must pass three phases of clinical testing before it is approved by a country’s regulatory authority and made available to the public.

Phase 1

The investigational drug is given to a small group of healthy volunteers or people with the target disease/condition. Researchers aim to learn how much of the investigational drug is safe to take and how the human body responds to it.

Phase 2

The investigational drug is given to a small group of people with the target disease or condition it is intended to treat. In this phase, researchers may evaluate what dose is appropriate and begin to test the safety and effectiveness of the investigational drug.

Phase 3

Researchers test the safety and effectiveness of the investigational drug in a larger group of people over a longer period than in Phase 2. Sometimes comparisons are made between the investigational drug and other medications that are already approved for the same purpose.

The investigational drug (VE303) in the RESTORATiVE303 Study has now successfully completed Phase 1 and Phase 2 studies.

RESTORATiVE303 is a Phase 3 study.

Frequently Asked Questions

Contact Us

For more information, please contact:

Sin Ting, RN

Clinical Research Coordinator
Mobile: 647.533.9621
Email: sting@viableclinicalresearch.com