Due to the nature of Clostridium difficile infections, particularly the high rate of recurrence following standard treatments, participating in a clinical trial may be an option for sufferers who don’t respond to antibiotics. Some clinical trials focus on developing vaccines and other preventatives. Those trials often need healthy volunteers who haven’t had a CDI to participate. The following are large, active trials focused on C. diff treatment and prevention. For smaller scale and local trials, please visit our In Your State page and search for ones near you.
What is a Clinical Trial?
A clinical trial is a research study that 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, please visit Clinical Trials.gov.
The PRISM 3 clinical study is for patients who have had a recurrence of Clostridium difficile infection (CDI or C. diff). The study is evaluating the safety and effectiveness of the study drug (CP101) to prevent recurrence of CDI compared to a placebo. The study is currently enrolling across the United States.
The study drug, CP101, is a Full-Spectrum Microbiota™ investigational drug designed to deliver bacteria to the intestine. This bacteria may help overtake the surplus of C. diff bacteria that cause CDI. CP101 is considered “investigational” because it has not been approved by the US Food and Drug Administration for treating CDI.
CP101 is encapsulated for oral administration. The powder is intended to be released from the capsules in the right part of your intestine where the bacteria may repopulate. This may aid in restoring the diverse community of bacteria found in the healthy human gut, which may prevent recurrence of C. diff.
Click here to learn more about PRISM 3 and see if there is a study near you and if you are eligible.
The PUNCH CD 3 study is a Phase 3 clinical study to evaluate the safety and efficacy of Rebiotix RBX2660 for the prevention of recurrent Clostridium difficile infection (CDI).
This prospective, randomized, double-blinded, placebo-controlled clinical research study is expected to enroll up to 270 patients at 60 research sites in the U.S. and Canada. Patients that meet the study requirements and choose to enroll will be randomized to received either RBX2660, an investigational new drug, or a placebo. Two out of every three study patients will receive RBX2660, and one out of every three study patients will receive the placebo study treatment (2:1 randomization). Study patients whose CDI returns within 8 weeks after blinded study treatment may be scheduled to receive an RBX2660 treatment (no placebo). The study’s primary endpoint will compare the proportion of patients with treatment success following treatment with RBX2660 to prevent recurrent CDI within 8 weeks of blinded treatment as compared to placebo.
To learn more or join the study, visit the ClinicalTrials.gov
Seres Therapeutics is developing Ecobiotic ® drugs designed to prevent C. diff infections from coming back again.
Most C. diff infections occur after antibiotic treatment. Why? Our gut contains trillions of microbes, called the microbiome, which protects us from bacterial invaders that can cause disease. Antibiotics kill both good and bad bacteria, leaving holes in this ecology (community) of microbes. When the microbiome is damaged, bad bacteria, like C. diff, can take advantage and cause disease. Although specific antibiotics can kill the active C. diff bacteria, the sleeping forms (ie, spores) are untouched. These spores turn into active C. diff bacteria and cause disease again and again – usually after antibiotic treatment has finished.
Seres Therapeutics has developed an oral medicine called SER-109, which aims to prevent C. diff from coming back by repairing the microbiome. This Ecobiotic® drug is being studied in a large Phase 3 clinical trial that is enrolling patients who have had multiple C. diff infections. This important clinical study is being done in the United States and Canada and may provide the final clinical data needed to support FDA drug approval. For more information, please follow this link to the patient website
Seres Therapeutics is also enrolling patients into a Phase 1 trial for SER-262, which is an Ecobiotic ® drug for those experiencing their first C. diff infection. For more information, please follow this link
National Institute of Allergy and Infectious Diseases (NIAID) is conducting a multi-center, randomized, placebo controlled, partially blinded trial comparing the safety and efficacy of fecal microbiota transplantation versus placebo both delivered by rectal enema in subjects 18 years of age or older with recurrent Clostridium difficile Associated Disease (CDAD). 162 male or female subjects will be enrolled in the study. Enrolled subjects will be randomized at each site to receive either FMT by enema or placebo by enema in a 2:1 ratio. Study duration is 4 years, subject participation duration is approximately 3 years. Primary study objectives are to: 1) evaluate the safety of FMT(s) delivered by enema vs. placebo delivered by enema, 2) determine efficacy of FMT delivered by enema vs. placebo delivered by enema.
For more information, please follow this link to ClinicalTrials.gov
Vaccine & Preventatives
The Da Volterra clinical study is for hospitalized patients requiring a systemic antibiotic treatment for a proven or strongly suspected bacterial infection who have a history of Clostridium difficile infection (CDI or C. diff) or are over 65 years of age. The study is evaluating the safety and effectiveness of the study drug DAV132 to prevent the emergence of antibiotic-resistance infections compared to a placebo. This clinical study is for patients in Bulgaria, Germany, Romania and Serbia.
The study drug, DAV132, is a novel therapeutic option for preserving the intestinal microbiota. This may aid in preserving the diverse community of bacteria found in the healthy human gut, which may prevent the emergence or reoccurrence of a Clostridium difficile infection (CDI). DAV132 is encapsulated for oral administration.
DAV132 is regulated as a medical device in Europe and as a drug in the United States of America. DAV132 is considered “investigational” because it has not been approved by the US Food and Drug Administration for treating CDI.
Click here to learn more about DAV132 and see if there is a study near you and if you are eligible.
A global, multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the ability of SYN-004 to degrade certain IV beta-lactam antibiotics within the GI tract to maintain the natural balance of the gut microbiome for the prevention of C. difficile infection, C. difficile associated diarrhea and antibiotic-associated diarrhea in patients hospitalized for a lower respiratory tract infection and receiving IV ceftriaxone. Click here to see if there’s a study site in the U.S. near you and if you’re eligible. Click here to learn more about SYN-004.