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.
MGB Biopharma Ltd. is developing a potent, novel bactericidal antibiotic to treat Clostridium difficile Infections (CDI). Current CDI treatments are largely bacteriostatic against C. difficile, suppressing growth and triggering sporulation. Consequently, the disease reoccurs in approximately one third of patients. Prevention of recurrence has become the highest unmet medical need and focus of development in new CDI therapy. MGB-BP-3 has been specifically developed for the treatment of CDI. It has a very potent and fast bactericidal effect which, in contrast to current CDI treatment, is capable of killing C. difficile in its vegetative form before it can sporulate, therefore speeding up recovery and preventing the disease from recurring.
A Phase II study with MGB-BP-3 is ongoing in North America, with completion expected in early 2020. This is an open labelled Phase II study to assess the safety, tolerability and efficacy of incremental doses of MGB-BP-3 in patients with CDI. Testing of the first two dose groups has been completed and recruitment in the last dose group is ongoing. Data so far indicate that it has very good tolerability and clear superiority compared to published data on vancomycin.
The drug has been granted Qualified Infectious Disease Product (QIPD) and Fast Track Designation by the U.S. FDA.
Some key information about the trial:
- There are 3 incremental dose groups of MGB-BP-3 in the trial, each containing 10 patients (125mg b.i.d., 250mg b.i.d. and 500mg b.i.d.)
- Patients must be 18 years or older
- Patients must have mild or moderate CDI to be eligible
- There are additional inclusion criteria that must be reviewed before patient is decided to be eligible for the clinical trial by the study doctor, and the patient must also provide consent to participate.
Status: Currently recruiting
Locations: This study is currently being conducted in the following areas: Calgary (Alberta, Canada), Annapolis (MD), Idaho Falls (ID), New Orleans (LA), Butte (MT), Orlando (FL), Houston (TX), Fairfax (VA) and Miami (FL). To learn more or join the study, visit the ClinicalTrials.gov
Prolacta Bioscience is a company dedicated to Advancing the Science of Human Milk. It has recently developed a pharmaceutical consisting of beneficial components derived from human milk and is investigating its usefulness in the treatment of C. difficile associated diarrhea.
In a healthy individual, the bacteria population living in the gut (microbiome) provides many health benefits and can prevent pathogens from causing infections. Antibiotics wipe out the beneficial bacteria in the gut and can allow the harmful bacteria, C. difficile to overgrow. C. difficile causes disease by producing toxins that injure the cells of the gut wall. Although some specific antibiotics can cure C. difficile infections, at times the pathogen can resist antibiotics by forming spores. These C. difficile spores are immune to the effects of antibiotics and, under certain conditions, can become harmful active bacteria which start the disease cycle all over again. If the gut Microbiome does not return to a healthy state, the C. difficile infection will continue to recur (come back) after each antibiotic treatment. Prolacta’s new product has natural biological activities that could help restore the individual’s healthy gut Microbiome and support immune functions to decrease relapses of C. difficile disease, without having to introduce a new bacterial population collected from outside sources.
Study Product: liquid product (consisting of human milk-derived components) or placebo, administered orally three times daily for seven days.
Study Phase: I
Study Design: double-blind, randomized, placebo-controlled dose escalation trial. Study subjects will receive one of three doses depending upon which dose group is recruiting at the time of their participation.
Population: individuals age 18 or older who have had no more than four prior occurrences of C. difficile associated diarrhea and are currently being treated with standard of care antibiotics. The target enrollment number is between 48 and 54.
Status: Currently Recruiting
Locations: This study is currently being conducted in the following areas: Idaho Falls, ID, Billings, MT, Omaha, NE, Orlando, FL, Miami-Dade, FL, New York, NY and Ventura, CA.
For further information contact: (888) 776-5228 email@example.com
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.
Ridinilazole is being developed by Summit Therapeutics as a potential treatment for C. difficile infection (CDI). It’s a new antibiotic, and Summit is testing whether it can improve patient outcomes over the current standard of care, vancomycin, in two global clinical trials. In an earlier clinical trial in patients with CDI, ridinilazole was found to be superior to vancomycin in a measure called sustained clinical response, which tested if patients were cured after treatment and did not experience a recurrence within 30-days post-treatment. More information on ridinilazole can be found by visiting www.summitplc.com/our-programmes/c-difficile-infection.
Some key information about the trials:
- Each trial is expected to enroll up to 680 patients
- Patients will be randomized to receive either ridinilazole or vancomycin, and neither the patients nor the study doctors will know which drug they receive
- Participation will involve about 7 study visits over approximately 100 days to track the safety and effectiveness of each drug
- Patients who participate may be reimbursed for travel expenses associated with study site visits
- Patients must be 18 years of age or older
- Patients must have signs and symptoms of CDI, including diarrhea, in the 24 hours prior to entry in the trial and a positive toxin test on a stool sample produced within 72 hours of entry into the trial
- Patients cannot have had more than one prior episode of CDI in the previous three months or more than three episodes in the past 12 months
- Patients cannot have had more than 24 hours of CDI antibiotic treatment prior to entry into the trial
- There are additional entry criteria and considerations; the study doctors will ultimately decide whether a patient is eligible for entry into the clinical trials and the patient will be required to give consent
Further details of the global clinical trials can be found by visiting: https://clinicaltrials.gov/ct2/show/NCT03595566 and https://clinicaltrials.gov/ct2/show/NCT03595553, and/or by speaking with one of the clinical trial sites.
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.
The results of Phase 1 study of VE303 in healthy volunteers showed both rapid expansion of protective VE303 bacteria in the gut and accelerated recovery to a healthy microbiome after disruption to the normal microbiome in the gut caused by antibiotics. Based on these positive Phase 1 results, Vedanta is now evaluating VE303 in a Phase 2 clinical study (CONSORTIUM) in participants with recurrent CDI to see if it can prevent future CDI recurrences by restoring the intestinal bacteria to a healthy state.
Up to 146 participants over the age of 18 years old with any number of recurrent CDI episodes including the current episode will be enrolled in the CONSORTIUM study. Two out of every three study patients will receive VE303, and one out of every three study participants will receive the placebo study treatment (2:1 randomization) upon completion of standard antibiotic treatment. CONSORTIUM’s primary study objective will be to determine the safety and efficacy of VE303 at preventing CDI recurrence within 8 weeks of completion of antibiotic treatment.
CONSORTIUM is currently recruiting participants across North America (U.S. and Canada). If you or someone close to you has been diagnosed with recurrent CDI, you may be eligible to take part in the study. To learn more about the study and to locate a study site near you, please visit: https://www.clinicaltrials.gov/ct2/show/NCT03788434.
If you are interested in study participation, please visit The Consortium Study recruitment page.
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.
The purpose of the Clover Trial is to evaluate the safety and efficacy of an investigational vaccine in reducing the chances of getting sick due to C. diff. The knowledge gained from this study may help others in the future. Participation in this study is expected to last between 18 and 42 months and will require 5 office visits within the first 7 months. You will also receive periodic contact from the study team, including regular electronic reminders of your participation and routine telephone calls after 12 months and at the end of the study. Approximately 16,000 patients are expected to participate in the study globally. To learn more and see if you qualify, click here.