Every scientific research and development, every clinical trial in progress is a glimmer of hope………..HOPE for clinically safe and approved avenues to prevent and treat a C. difficile infection.
Listed below you will find a few examples of organizations who have active
C. difficile Prevention and Treatment clinical trials in progress. Click on each organization’s website listed to review their clinical trial study opportunities and inquire if you or your loved one qualify to participate in their study.
To Learn More About Clinical Trials —
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Learn more About Clinical Studies and About This Site, including relevant History, Policies, and Laws. Click on the link below to be redirected to the clinicaltrials.gov website: https://clinicaltrials.gov/
Clinical Studies Are In Progress To
Help Them — Help You — Help Others ♥
Here is a partial-listing and explanations of Clinical Trial Phases:
Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question.
- Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
- Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
THE FOLLOWING ARE A FEW EXAMPLES OF CLINICAL TRIALS AVAILABLE ADDRESSING C.difficile INFECTION PREVENTION AND TREATMENTS.
Visit clinicaltrials.gov for a full listing.
C. diff. Infection (CDI)_Prevention Clinical Studies
Da Volterra is a clinical-stage biotechnology company whose vision is to be a trusted and acknowledged leader in the microbiota field. Da Volterra’s mission is to discover, develop, and bring to market safe and novel therapeutic options, preserving patients’ microbiota to prevent and cure life-threatening diseases. Its most advanced product is DAV132, an oral product to be co-administered with any oral and intravenous antibiotics, to protect patients from antibiotic-induced intestinal microbiota disruption. DAV132 can prevent Clostridioides difficile infection by capturing residual antibiotics in the colon before they can disrupt the intestinal microbiota, without impacting the systemic efficacy of the antibiotics.
We see DAV132 as a real game-changer for C. difficile prevention.
Have a look at the DAV132 webpage and video presenting its mechanism of action: https://davolterra.com
The video is highly illustrative of what C. diff. is, how C. diff. is triggered, and how DAV132 could prevent the colonization of the intestinal microbiota by C. diff. and the occurrence of the infection.
Da Volterra has already performed 6 phase 1 clinical trial with DAV132 in healthy volunteers and one phase 2 clinical trial (SHIELD) in patients demonstrating DAV132 favorable safety profile and mechanism of action. The SHIELD study met its primary endpoint: DAV132 was very safe for use in hospitalized patients with several comorbidities and concomitant medications. The study also demonstrated positive results with regards to biological markers of efficacy for prevention of C. difficile infection: DAV132 effectively protected the intestinal microbiota of patients from antibiotic-induced disruption and DAV132 also prevented the proliferation of C. difficile in an ex vivo assay, suggesting that DAV132 is able to protect patients against antibiotic-induced C. difficile infection.
The press release on Da Volterra’s phase 2 SHIELD study results is available here: https://davolterra.com/wp-content/uploads/2020/02/2020-02-11-dav132-phase-2-clinical-trial-pr-vf.pdf
Da Volterra is now preparing for the launch of phase 3 pivotal study of DAV132 in patients who have a high risk of developing Clostridioides difficile infection.
Information on this study is available here: https://clinicaltrials.gov/ct2/show/NCT03710694
Summit Therapeutics 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 a 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
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.
The clinical trials will be taking place at sites in the US, Europe, Latin America, Australia, and Asia. If you would like to be considered for enrollment into one of the clinical trials, please contact the study site nearest you.
ridinilazole has already received Qualified Infectious Disease Product, or QIDP, designation and has been granted Fast Track status from the US Food and Drug Administration
To learn more about ridinilazole and Summit Therapeutics, click on the following link to be redirected to the Summit Therapeutics website: https://www.summitplc.com/
Visit www.ricodify.com online resources for patients with CDI and their caregivers. The website also includes a map of clinical sites, which is searchable by postcode.
Pfizer, a leader in vaccine research and innovation, continues to advance its Clostridium difficile (C. difficile) vaccine candidate, PF-06425090. The Phase 3 trial CLOstridium difficile Vaccine Efficacy TRial (CLOVER), is an ongoing placebo-controlled trial designed to assess whether PF-06425090 prevents the disease, and whether it is safe and well-tolerated in adults 50 years of age and older. [i], [ii]
Additional information about CLOVER can be found at CloverTrial.com.
i] Clover Trial. Available from: https://clovertrial.com/en/. Accessed July 31, 2019.
[ii] Pfizer. Clostridium Difficile Vaccine Efficacy Trial (Clover). In:ClinicalTrials.gov [Internet]. [cited 2019 July 31]. Available from: https://clinicaltrials.gov/ct2/show/NCT03090191. NLM Identifier: NCT03090191.
“Is another C. diff. infection getting in the way of your life?”
Seres Therapeutics is developing Ecobiotic® drugs designed to prevent C diff infections from coming back again.
Most Clostridioides difficile (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 disrupt the microbiome by killing both good and bad bacteria. 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 inactive forms (i.e. C diff spores) are untouched. When the microbiome is disrupted, these spores turn into active C diff bacteria and cause disease again and again – usually after antibiotic treatment has finished.
Seres Therapeutics is developing an investigational microbiome drug called SER-109. This medicine is being developed to prevent C diff from coming back by repairing the microbiome. Seres is pleased to announce the positive top-line results from its ECOSPOR-III trial reported in August 2020. In a placebo-controlled randomized trial of 182 patients with a multiple (> 3) recurrent C. diff infection, the recurrence rate was significantly reduced from 41.3% in placebo recipients to 11.1% in the SER-109 recipients. In addition, SER-109 was well tolerated. Based on these encouraging results, Seres is now enrolling an open-label study, in which all participants will receive SER-109. This new study will be open to patients experiencing their first recurrence or multiple recurrences of C. diff at sites in the US and Canada.
To learn more about Seres Therapeutics and Clinical Trials In Progress please click on the following link to be redirected:
Vedanta Biosciences, Inc. is a clinical-stage microbiome company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria.
VE303 is a defined bacterial consortium designed to prevent recurrent C. difficile infections (“CDI”). VE303 is a preparation of eight different bacteria that were selected for their presumed ability to prevent the regrowth of C. Difficile.
Why bacterial consortia?
Unlike fecal transplants, which require the use of donors’ stool and are an inherently variable procedure, bacterial consortia therapeutics are defined drug compositions produced from clonally isolated bacteria that can trigger targeted immune responses. And unlike reductionistic approaches such as single strain probiotics, they can robustly shift the gut ecosystem.
The results of the Phase 1 study of VE303 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 Phase 1 results, Vedanta is now evaluating VE303 (the “CONSORTIUM” study) in individuals with CDI to see if it can prevent future CDI recurrences by restoring the intestinal bacteria to a healthy state.
CONSORTIUM (NCT03788434) is a randomized, double-blind placebo-controlled Phase 2 study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD), and efficacy of VE303 in patients with a recent diagnosis of CDI, who have completed a course of antibiotics but remain at risk for recurrence. The primary endpoint will be the prevention of infection recurrence at eight weeks.
CONSORTIUM is currently enrolling participants across North America (U.S. and Canada) who have been diagnosed with high-risk CDI.
For additional study information or to locate a study site near you, please visit Clinicaltrials.gov:
If you have questions about the study or are interested in study participation, please email:
Please take a moment to view a brief presentation, created by Vedanta Biosciences, to learn more about
C. difficile infections, treatments, and clinical trials
Valneva Clinical Trial of its Clostridium difficile vaccine candidate
UPDATE: February 2019
Valneva’s Clostridium difficile vaccine candidate – VLA84
Valneva successfully completed Phase 2 development of its prophylactic vaccine candidate against Clostridium difficile infection, confirming previously announced positive topline data. The vaccine candidate VLA84 is Phase 3 ready.
Valneva seeks to partner its Clostridium difficile vaccine candidate. At this point, however, potential partners are hesitant about the level of investment required to fund a Phase 3 clinical trial. Therefore, the Company reviewed its development and partnering approach. Valneva will consider using the first CDI vaccine approval and to conduct a head to head, non-inferiority Phase 3 trial, based on an immunological correlate that is expected to substantially improve the investment – risk profile of an in-house, or partnered, development to market.
BACKGROUND: Lyon (France), December 18, 2014 – European biotechnology company Valneva SE (“Valneva”) announced today the initiation of Phase II clinical trial of its VLA84 prophylactic vaccine candidate against Clostridium difficile (C. difficile), the main cause of nosocomial diarrhea. Data from the Phase I study in healthy elderly and adults showed good safety and immunogenicity of the vaccine candidate, and indicated functionality of induced antibodies, supporting the Company`s decision to progress the vaccine
candidate into Phase II
C. diff. Infection (CDI) Treatments
In this Phase 2 clinical trial, Segment 2A was designed to enroll up to 20 patients with a data review planned by a Trial Oversight Committee after 10 patients completed the trial. All 10 patients enrolled in the trial met the study’s primary and secondary efficacy endpoints of Clinical Cure at end of treatment and Sustained Clinical Cure of no recurrence of CDI at the 28-day follow-up visit. Ibezapolstat was well-tolerated, with no serious adverse events (SAEs) reported in the trial. Based on these successful treatment results, and in consultation with the Company’s medical advisors, the Company has terminated enrollment in Segment 2A early and will advance to Segment 2B. These results also represent the first-ever clinical validation of DNA polymerase IIIC as a therapeutically relevant antibacterial target.
Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for the microbiome aspects of the trial stated, “Data from my laboratory confirm that ibezapolstat eradicated C. difficile in all fecal samples tested by Day 3 of treatment in this patient population with mild or moderate CDI. Our ongoing work will characterize the effects of ibezapolstat on the intestinal microbiome in these CDI patients. A strength of this development program will be the ability to compare the microbiome results in CDI patients to our prior favorable effects relative to vancomycin previously demonstrated in the Phase 1 healthy volunteer trial.”
Stuart Johnson, MD, Professor of Medicine at Loyola University, a CDI expert and an Acurx Scientific Advisory Board (SAB) member, noted, “After reviewing Segment 2A , the SAB is encouraged by the promising results and fully support early termination and advancement to the Ph2B Segment with the next enrolled patient. The SAB looks forward to successful results from Segment 2B that could pave the way for an important new antibiotic class for the treatment of CDI which remains an area of clear medical need.”
These data will be presented at the 8th Annual International C. diff. Virtual Conference and Virtual Health Expo on November 14, 2020, https://cdiff2020.com which coincides with the US Centers for Disease Control and Prevention (CDC) declaration of November as Clostridioides difficile Awareness Month.
Robert J. DeLuccia, Co-Founder & Managing Partner of Acurx, stated, “We are very excited by these excellent results allowing early termination of our Phase 2A Segment at 10 patients. We are looking forward to starting our Phase 2B Segment early next year with expectation for completion by the end of next year”. He further stated, “since ibezapolstat is the first DNA polymerase IIIC inhibitor to advance into clinical trials, this achieves the first human validation of our bacterial target and will enable further development of our pipeline of novel oral and I.V. antibiotics with the same bacterial target and mechanism of action. Our new compounds are in pre-clinical development to treat other Gram-positive life-threatening infections in skin/skin structure, community-acquired pneumonia, bone & joint, and bacteremia. The spectrum of activity of Acurx’s DNA pol IIIC inhibitors includes pathogens resistant to currently available antibiotics and classified as priority pathogens by the WHO, CDC, and FDA, all of whom emphasize the need for new classes of antibiotics to prepare for the next global infectious disease pandemic, antimicrobial resistance.”
About the Phase 2 Clinical Trial. In Segment 2A of this trial, 10 subjects with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally for 10 days and evaluated for clinical cure. All cured subjects were followed for a sustained clinical cure at 28 ± 2 days. In Segment 2B, approximately 64 additional subjects with CDI will be enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours for 10 days and will be followed for 28 ± 2 days for recurrence. The two treatments will be identical in appearance, dosing times, and the number of capsules administered to maintain the blind. Subjects in both segments will be evaluated for clinical and sustained clinical cure, safety, and tolerability. All subjects in both segments will have stool samples tested for microbiome profiles. Additional information about the trial, including eligibility criteria, can be found at www.clinicaltrials.gov (Study identifier: NCT04247542).
About Clostridioides Difficile Infection (CDI). Clostridioides (formerly Clostridium) difficile, also known as C. difficile or C. diff, is one of the most common causes of healthcare-associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the United States and are associated with approximately 20,000 deaths. (Guh, 2020, New England Journal of Medicine). Based on internal estimates including a recurrence rate of approximately 20%, we believe the annual incidence in the U.S. approaches 600,000.
About the C Diff Foundation: The Company recognizes the month of November as C. Difficile Awareness Month as designated by the US Centers for Disease Control and Prevention (CDC) and supports the work of the C Diff Foundation in educating and advocating for the Prevention, Treatments, Clinical Trials, and Environmental Safety of Clostridioides difficile (C.difficile) Infections worldwide. https://cdifffoundation.org/. The C Diff Foundation recently announced the release of the C diff and You app, available from the Apple Store (apple.com) and Google Store (play.google.com). Developed with patients, family members, and caregivers in mind, the app provides information about C. difficile infection prevention, treatments, clinical trials, support, guidelines, environmental safety, and nutrition.
The U.S. Center for Diseases Control 2019 Update on Antimicrobial Resistance. https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf CDC reported that more than 2.8 million antibiotic-resistant infections occur in the U.S. each year and more than 35,000 people die as a result, nearly twice as many annual deaths as previously reported by CDC in 2013. These deaths are attributed to antimicrobial-resistant pathogens including Enterococcus (including vancomycin-resistant strains or VRE), Staphylococcus (including methicillin-resistant strains or MRSA), and Streptococcus (including antibiotic-resistant strains), which are the targets of the Company’s antibiotic pipeline currently in preclinical development and also eligible for QIDP and FDA-Fast-Track-Designation for priority review.
About ibezapolstat, FDA QIDP, and Fast Track Designation. In June 2018, FDA granted Qualified Infectious Disease Product (QIDP) designation to ibezapolstat as an oral treatment for patients with CDI. In addition, in January 2019, FDA granted Fast Track designation to ibezapolstat for the oral treatment for patients with CDI.
FDA’s QIDP Designation provides that ibezapolstat will be eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (the GAIN Act). These incentives include Priority Review and eligibility for Fast Track status, the latter of which Acurx has already applied for and been granted by the FDA. Further, if ultimately approved by the FDA, ibezapolstat is eligible for an additional five-year extension of Hatch-Waxman marketing exclusivity.
FDA Fast Track Designation is a process designed to facilitate the development and expedite the regulatory pathway of new drugs to treat serious or life-threatening conditions and that fill a high unmet medical need. Ibezapolstat is a novel, first-in-class, orally administered antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors in clinical development by Acurx to treat bacterial infections.
About DNA polymerase IIIC (pol IIIC). Working in scientific collaboration with WuXi AppTec, Acurx has identified additional potential therapeutic candidates to add to its pipeline of DNA pol IIIC inhibitors. Nonclinical research has established the mechanism of action of ibezapolstat as the selective inhibition of the enzyme DNA polpol IIIC, which is required for bacterial replication and pathogenesis. This enzyme is found only in certain Gram-positive bacteria, including C. difficile as well as the pathogens Enterococcus (including vancomycin-resistant strains or VRE), Staphylococcus (including methicillin-resistant strains or MRSA), and Streptococcus (including antibiotic-resistant strains). Accordingly, chemically related molecules with the same mechanism of action as ibezapolstat have the potential to treat a variety of serious systemic Gram-positive infectious diseases.
About Acurx Pharmaceuticals, LLC. Acurx Pharmaceuticals is a privately-held clinical-stage biopharmaceutical company focused on developing new antibiotics for difficult-to-treat infections. Acurx’s approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes early-stage antibiotic candidates that target other Gram-positive bacteria, including Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and Penicillin-Resistant Streptococcus pneumoniae (PRSP).
For more information, please visit our website at www.acurxpharma.com.
SOURCE Acurx Pharmaceuticals, LLC Released November 5, 2020
- Having reached a sufficient number of clinical centers, Phase II clinical trial testing the antibiotic candidate DNV3837 in Clostridioides (Clostridium) difficile infections will start this summer in the United States and Germany
- This trial will be conducted as part of an active Investigational New Drug (IND) authorization and a recently updated version of the clinical protocol
- The production of the first commercial batch of DNV3837 has been successfully initiated
DEINOVE (Euronext Growth Paris: ALDEI), a French biotech company that uses a disruptive approach to develop innovative antibiotics and bio-based active ingredients for cosmetics and nutrition, announced that all the conditions are in place for the upcoming start of the Phase II trial testing the antibiotic candidate DNV3837 for the treatment of Clostridioides difficile infections.
DNV3837 is a first-in-class antibiotic candidate targeting the treatment of Clostridioides difficile infections (CDIs), a disease classified as a priority by the WHO and one of the global leading causes of healthcare-related infections. DNV3837 has demonstrated a promising efficacy profile, an acceptable tolerance in Phase I trials. It has obtained a QIDP designation and a Fast Track status[
DNV3837 will now enter the Phase II trial for the treatment of CDIs. The clinical protocol has recently been adjusted and allows the trial to be conducted under the IND initially granted for the compound.
This multicentric open-label trial will be conducted both in Germany and the United States. Under the updated protocol, the number of sites, necessary for the implementation of its Phase II, has been reached. The inclusion of the first patient is planned for mid-2019. Medpace (Nasdaq: MEDP) was chosen as the Clinical Research Organization to oversee the trial.
In parallel, DEINOVE has started the production of the first DNV3837 batch on a commercial scale, in accordance with good manufacturing practices. This batch will be used in order to prepare enough material for conducting the Phase III trial. CMC (Chemistry, Manufacturing, and Controls) operations in the United States have been contracted to a recognized CMO and the first production steps have been successfully completed in accordance with the agreed specifications.
For more information: http://www.deinove.com/en
Rebiotix Inc. is a clinical-stage biotechnology company founded to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome. Microbiota Restoration Therapy (MRT) is the company’s platform for delivering live microbes into a sick patient’s intestinal tract to treat disease.
The PUNCH CD3-OLS study is a Phase 3 clinical study to assess the safety and tolerability of Rebiotix RBX2660 for the prevention of recurrent Clostridium difficile infection (CDI) in a recurrent CDI population that is broader and more inclusive than that included in prior studies using RBX2660.
This open-label study is expected to enroll up to 200 patients at 80 research sites in the U.S. and Canada. Patients that meet the study requirements and choose to enroll will receive RBX2660, an investigational new drug (no placebo). Study patients whose CDI returns within 8 weeks after study treatment may be scheduled to receive additional RBX2660 treatment. The study’s primary objective is to assess the safety and tolerability of RBX2660 through 6 months after the final RBX2660 study treatment.
Additional information can be found on the Clinicaltrials.gov website https://clinicaltrials.gov/ct2/show/NCT03931941
Or through the Rebiotix website: https://www.rebiotix.com/
Rebiotix Inc., part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT™ drug platform. The MRT platform is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract. The lead drug candidate, RBX2660, is currently in Phase 3 clinical development for the prevention of recurrent Clostridium difficile(C. diff) infection. RBX2660 has been granted Fast Track status, Orphan Drug, and Breakthrough Therapy designation from the US FDA for its potential to prevent recurrent C. diff infection. Rebiotix’s clinical pipeline also features RBX7455, a lyophilized, non-frozen, oral capsule part of a recently completed investigator-sponsored Phase 1 trial for the prevention of recurrent C. diff infection. For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit www.rebiotix.com.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing, and marketing innovative products in the fields of reproductive health, women’s health, urology, gastroenterology, endocrinology, oncology, and orthopaedics. For more information, visit www.FerringUSA.com.
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 the recurrence of CDI compared to a placebo. The study is currently enrolling across the United States.
http://www.ClinicalTrials.gov click on the following link:
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 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..
CP101 drug products are in development and investigational at this time. No product has yet been approved by the U.S. Food and Drug Administration. Prolacta Bioscience is a company dedicated to Advancing the Science of Human Milk. It has been leading the way in developing human milk-based nutritional products for premature and other infants with special nutritional needs since 2005.
Prolacta has recently developed a potential therapeutic, 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 harmful bacteria such as 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 may still return 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 function in order to potentially reduce the risk of a relapse of C. difficile disease without having to introduce a new bacterial population collected from outside sources.
Some Key Information about the trial:
• Patients will be given liquid product (consisting of human milk-derived components) or placebo, administered orally three times daily for seven days
• Phase I Study
• 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.
• Currently enrolling patients age 18 or older who have had no more than four prior occurrences of C. difficile associated diarrhea (CDAD) and are currently being treated with standard of care antibiotics.
• The target enrollment number is between 48 and 54.
The clinical trial will be taking place at the following locations in the US:
– Idaho Falls, ID Orlando, FL
– Butte, MT Miami-Dade, FL
– Omaha, NE Tampa, FL
– Ventura, CA New York, NY
For further information contact: firstname.lastname@example.org
case/control number C.diff. trial : NCT03793686
2/2019 : A PARTIAL LIST OF CLINICAL TRIALS UPCOMING
“The C Diff Foundation’s mission is to educate and advocate for Clostridium difficile infection prevention, treatments, support, and environmental safety worldwide.
The C Diff Foundation’s organization is comprised of 100% volunteering members who are dedicated to our mission and adhere to the Foundation’s Code of Ethics
which prohibits the endorsement and paid promotion of products, services, medications, or clinical studies in progress.
All website entries, public presentations, and workshops are to raise C. diff. infection awareness in all areas of the C Diff Foundation’s mission statement, including, and not limited to, infection prevention, sepsis, healthcare-associated infections, antimicrobial resistance, antibiotic stewardship and provide education on all the above.”