FEATURED RESEARCH

While you can find a comprehensive list of C. diff trials using our In Your State database, this page highlights participants in our paid Clinical Trial Awareness program. If you sponsor or plan to sponsor a clinical trial and would like to be enrolled in the program, you can contact us here. 

ABOUT CLINICAL TRIALS

A clinical trial is a research study using human volunteers that is intended to add to medical knowledge. Clinical trials can vary in size from a single location in one country to multiple locations in multiple countries. Some research studies may determine if an investigational product can be administered to children or special populations. Some studies assess a drug’s long-term effectiveness and its impact on the quality of a person’s life.

All studies of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB) or Ethics Committee (EC). All clinical trials are conducted using Principles of Good Clinical Practice (GCP) and are under the supervision of an IRB or EC whose mission is to ensure the safety and welfare of study participants. To learn more about clinical trials, visit Clinical Trials.gov.

RECURSION, REC-3694

Recursion is working to decode biology to radically improve lives through tools like automation, new biological tools, and artificial intelligence. Using these tools, they believe they can generate intelligent maps of biology and navigate those maps to more effective medicines. They are developing REC-3964, an investigational drug that has been shown to minimize the harmful effect of the C. difficile bacteria toxins on the colon in animal studies. It is expected to help prevent C. difficile infections from recurring.

The purpose of the ALDER trial is to investigate the safety, tolerability, pharmacokinetics and efficacy of REC-3964 for the reduction of recurrent CDI after initial cure with vancomycin. Participants may receive treatment with REC-3964 for 28 days or be placed in an observation group.

This is an open-label study, which means you will know which group you are placed in. The study will be conducted at several locations in the United States and will include about 80 participants divided into three groups. You have a 1 in 2 chance of being placed in the high dose group, and a 1 in 4 chance of being placed in either the lower dose group or the observation group (where you won’t receive REC-3964). The total study duration for each participant is up to 77 days.

If you are interested in participating, please visit https://www.aldercdiff.com/ to find a testing location near you.

VEDANTA BIOSCIENCES, VE303

Vedanta Biosciences, Inc. is dedicated to finding treatments for patients with serious infections and immune diseases. VE303 is Vedanta’s investigational treatment for patients with recurrent C. difficile infections (CDI). VE303 is a preparation of eight different types of bacteria grown in clean conditions, dried, powdered and put into capsules to be administered orally. The bacteria are reactivated once they reach the intestines. The 8 bacteria were selected for their ability to provide resistance against C. difficile. In contrast to fecal transplants, which rely on direct sourcing of fecal donor material of inconsistent composition, VE303 is manufactured from pure cell banks that yield a product of uniform composition, free of viruses and uncharacterized bacteria.

In April 2023, Vedanta published results from the Phase II CONSORTIUM trial. The press release can be found here.

PHASE III STUDY

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). You will be randomly assigned to receive one of two drugs: VE303 or placebo. Placebo looks like VE303 but contains no active medicine. You will be asked to attend around 11 study visits (7 at the study center and 4 virtually) to check on your health and well-being. You will also be given your assigned study drug. You will remain in the study for around 6 months.

An open-label extension to this study is available if you experience a recurrence of CDI while taking part. This means you will receive VE303 for 14 days and not a placebo. This is optional, however, and you do not have to accept this if it is offered to you. You can read more about this study and find a complete list of study locations here.

Vedanta Biosciences has teamed up with Science37 to provide a site-less, decentralized approach. This means the study can be done remotely and the product comes to you, in your home. This allows applicants who are not near a study site or unable to travel to participate and receive treatment. You can sign up for the decentralized study here.