Tag Archives: C. diff. treatment clinical trials

Fight C. diff. With A Non-Toxic Strain Of C. diff

In The News:

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Dale Gerding, M.D., a professor of medicine at Loyola University’s Stritch School of Medicine in Chicago says, “Antibiotics disrupt your normal microbiota and when they do that they enable you to be susceptible to C. diff.”

Even after treatment, C. diff comes back in 20 percent of patients.

O’Riordan had it six times in less than a year.

Dr. Gerding has patented a novel treatment to prevent recurrence by giving patients a non-toxic strain of C. diff.

“Instead of replacing the microbiota, which is what a fecal transplant does, all this does is replace the C. Diff,” explains Dr. Gerding

Stuart Johnson, M.D., an infectious disease physician and professor of medicine at Loyola University’s Stritch School of Medicine says, “You can think of it as a probiotic, we like to think of it as a bio-therapeutic.”

They believe a non-toxic strain of C. diff could be the answer to protecting hundreds of thousands of people against the fastest growing superbug.

“I don’t want to go through this again, ever. Ever! Anything even remotely like that,” says O’Riordan.

Dr. Gerding said the non-toxic strain of C. diff doesn’t have any serious side effects, and it stays in the body for up to five months, which is why it cut the recurrence rate to two percent in studies.

Dr. Gerding is currently looking for a company to develop the treatment. It would be given in pill or liquid form.

For article in its entirety please click on the link below:

http://www.wtvm.com/story/32162456/fighting-c-diff-with-c-diff

Summit Therapeutics To Present Further Data Showing Superiority Of Its New Antibiotic At the 26th ECCMID Conference

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Summit Therapeutics is to present further data showing the superiority of its new antibiotic for hospital superbug C.diff. over the standard of care medicine.

The additional data on Summit’s ridinilazole versus vancomycin comes from the from the Phase 2 CoDIFy trial and will be heard at the 26th European Congress of Clinical Microbiology and Infectious Diseases Conference  (ECCMID).

(ECCMID 2016  Will be hosted in Amsterdam from 9 – 12 April )

Taking the antibiotic ridinilazole resulted in a marked reduction in rates of C. diff. (CDI) recurrence as compared to vancomycin (14.3% versus 34.8%) the drug discovery firm will say.

This result comes on top of t previously reported statistical superiority in ‘sustained clinical response’ rates of ridinilazole over vancomycin (66.7% compared to 42.4%) for treating the disease.

Sustained clinical response is defined as clinical cure at the end of treatment and no recurrence of the condition in 30 days after therapy.

C. diff is a serious threat in hospitals and care homes and there are between 450000 and 700000 cases in the US annually.

Recurrence is a key problem as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs.

 

 

To read the total article, click on the following link:

http://www.menafn.com/1094678222/Summit-Therapeutics-to-present-further-data-showing-ridinilazoles-superiority

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

 

 

 

Scientific research demonstrates new evidence supporting Fecal Microbiota Transplant successful in treating C. difficile infections

Research published in the open access journal Microbiome offers new evidence for the success of fecal microbial transplantation (FMT) in treating severe Clostridium difficile infection (CDI), a growing problem worldwide that leads to thousands of fatalities every year.

Research led by Michael Sadowsky, Alex Khoruts, and colleagues at the University of Minnesota in collaboration with the Rob Knight Lab at the University of Colorado, Boulder, reveals that healthy changes to a patient’s microbiome are sustained for up to 21 weeks after transplant, and has implications for the regulation of the treatment. Findings also demonstrate the dynamic nature of fecal microbiota in FMT donors and recipients.

In FMT, fecal matter is collected from a donor, purified, mixed with a saline solution and placed in a patient, usually by colonoscopy. In contrast to standard antibiotic therapies                                (e.g., Vancomycin)  which further disrupt intestinal microflora and may contribute to the recurrence of CDI, FMT restores the intestinal microbiome and healthy gut function.

Using DNA samples of healthy individuals from the Human Microbiome Project (HMP) as a baseline, Sadowsky and his team compared changes in fecal microbial communities of recipients over time to the changes observed within samples from the donor. Significantly, the composition of gut microbes in the both donor and recipient groups varied over the course of the study, but remained within the normal range when compared to hundreds of samples collected by the HMP.

According to Sadowsky, the findings have important implications for a range of diseases associated with microbial imbalance, or dysbiosis, and could influence the regulatory regime surrounding FMT, currently treated as a drug by the U.S. Food and Drug Administration (USFDA).

“The dynamic nature of fecal microbiota in both the donor and recipients suggests that the current framework of regulation, requiring consistent composition, may need to be reexamined for fecal transplantations,” says Michael Sadowsky. “Change in fecal microbial composition is consistent with normal responsiveness to shifts in the diet and other environment factors. Variability should be taken into account when comparing microbial composition in normal individuals to those with dysbiosis characteristic of disease states, especially when assessing clinical interventions and outcomes.

Also discovered in the research, the performance of frozen and fresh preparations of fecal material was indistinguishable. Though the sample was limited and warrants further study with a larger cohort, it has several implications for the widespread adoption of FMT. The frozen preparation greatly simplifies the standardization and distribution of the fecal material. It also facilitates long-term storage of donor material for future study and makes FMT accessible to a greater number of physicians and patients. Finally, it offers advantages over fresh material in the testing of fecal samples for pathogens, which in some cases can take several weeks to complete.

While FMT is particularly successful in patients who suffer from recurrent CDI, University of Minnesota researchers led by Sadowsky and Dr. Alex Khoruts are currently preparing for a clinical trial using FMT to improve insulin sensitivity in pre-diabetic patients and to treat metabolic syndrome.

 

To read the article in its entirety please click on the following link:

http://www.eurekalert.org/pub_releases/2015-04/uom-nes040915.php

Recurrent C. difficile Infection – Treatment; Rebiotix, Inc. Initiates Second Clinical Trial (PUNCH CD 2)

Rebiotixrecurrent-c-diff-clinical-study

Rebiotix Inc. is a results-oriented biotechnology company revolutionizing the treatment of challenging gastrointestinal diseases by harnessing the power of the human microbiome. The company has completed the PUNCH CD study which assessed the safety and efficacy of RBX2660 (microbiota suspension) for the treatment of recurrent        C. diff. It is now working with the US Food and Drug Administration on the design of additional studies needed to make this therapy widely available to patients suffering from this debilitating condition.

Updated  24 November 2014

Rebiotix has initiated their second clinical trial (PUNCH CD 2) focusing on the treatment of recurrent C. difficile infection!

The PUNCH CD 2 study is a Phase 2B randomized controlled trial to assess the effectiveness and safety of RBX2660 (microbiota suspension) for the treatment of                                   recurrent  Clostridium difficile (C. diff.)  infection.

About the Study:   The PUNCH CD 2 study is the first multicenter prospective, multicenter, randomized, placebo-controlled, double-blind study of a microbiota restoration therapy. It has been designed to provide the highest quality of evidence to-date about this non-antibiotic approach to treating recurrent C. diff. infection.

Approximately 117 patients at over 20 sites in the US and Canada are expected to be enrolled in study.

Patients will be randomized into three different study groups: one group will receive two enemas containing RBX2660; another group will receive two enemas without the active drug; and the third group will receive one enema with RBX2660 and one without.  If a patient’s C. diff. infection reoccurs before 8 weeks after treatment, he or she may be eligible to crossover to receive active treatment with RBX2660.

All patients will be followed for 24 months after treatment.

Further Study Details

For more information on the study you may:

Find Out if You Could be Eligible

A physician participating in the PUNCH CD 2 study will determine if you are eligible to participate in the study. However, you can take a brief survey (less than 1 ½ minutes to complete) to learn if you meet the major study eligibility criteria.

How to Enroll as a Participant

If a study physician thinks you may be a good candidate, you will be given complete information about the study including the responsibilities for participation. You can find out if there is a study site near you by reviewing the clinical study site locations for PUNCH CD 2.

The PUNCH CD 2 Study is now open for enrollment. It is posted on ClinicalTrials.gov 

The number is NCT02299570.

To access the clinical trial information, please click on the link provided below.

http://www.rebiotix.com/index.php/rebiotix-clinical-program/punch-cd-2-clinical-trial

For more information about Rebiotix, Inc. please click on the link below:

www.rebiotix.com

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.