Author Archives: cdifffoundation

Thanksgiving Reflections With Gratitude – 2017

Dear Members, Followers, and Visitors,

It’s hard to believe another  year has caught up with us and here we are preparing for the Thanksgiving holiday and reflecting upon the days that have passed by in 2017.

 

During this year we have been expanding across  the globe and reaching far away lands
meeting great people like you who are devoted to “Promoting C. diff. Awareness” with
the C Diff Foundation.

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We want to extend our gratitude to you and everyone for the warm welcome this past
year.  In our travels, and communication we get to discover many organizations doing outstanding work.

Each organization dedicated in researching and developing new avenues to prevent and treat a Clostridium difficile infection are all successful, appreciated, and applauded by the patients and their families who are being treated and recovering from a          C. difficile infection.

The C Diff Foundation is an exceptional organization, and its special ingredients
are what makes us so proud to be a part. The first of these is our outreach programs. We offer patients and their families opportunities worldwide to gain support and information which is vital during a C. diff. infection and during the recovery phase of this infection.

The second special ingredient is the dedicated volunteering staff here in the USA,  most of whom have been faithfully serving our Foundation since the formation in 2012.

The third special ingredient is you and all the Volunteer Advocates worldwide with the financial supporters who see to it that our mission continues promoting  “C. difficile Awareness” with the many programs in place to make you and your communities stronger than ever in C. diff. infection prevention, treatment information, support, and environmental safety products available.

CDiffAwarenessRibbon2015

As we work together today and in the coming  year, seeking opportunities to bring hearts to a mend through the C. diff. Global Community Support Program, we look forward to speak with you by phone via: Teleconferencing sessions or in person at a local event.  Sessions are scheduled each month and available throughout the US and accessible from 57 countries right now.  Register through the website support page or call us (919) 201-1512 and register for upcoming sessions.  It will be our pleasure to speak with you about C. diff. infections, financial support, pharmaceutical information, group discussions related to anxiety and depression, nutrition, and sessions speaking with others that truly understand the diagnosis and ways to work through it.

We encourage you to introduce others to the C Diff Foundation and to the validated information provided.

As we come together with friends, family, and strangers~  let us reflect on our own thoughts and reflections of gratitude and let us light a candle to signify “hope” – the shining light that we see in the shadows when turmoil and struggles occur.

The days may becoming shorter during the winter months on the horizon but our light of “hope” for better health and stronger days has never shown brighter than today.

 

 

 

 

We especially wish to thank the many USA Governors for signing State Proclamations declaring “November Clostridium difficile Infection Awareness Month.”

The gratitude expressed by the patients and their families is overwhelming and the health care professionals around the globe hold this statement in the highest regards.

“We are thankful!”

We are all truly grateful for the opportunity to work with dedicated volunteers, healthcare professionals, scientific researchers, and associates from so many worthy organizations.

Thank you for all that you do for others, for their communities – and partnering with the C Diff Foundation in  our mission of educating and advocating for C. difficile infection prevention, treatments, environmental safety, and support worldwide!

Rebiotix and the C Diff Foundation Applaud the State of Minnesota as it Declares November C. difficile Infection Awareness Month

 Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, and the C Diff Foundation have joined today to voice support for the State of Minnesota in declaring November “C. difficile Infection Awareness Month.

Rebiotix and the C Diff Foundation believe this important action by Governor Mark Dayton and his administration adds significant weight to the ongoing effort to prevent and treat Clostridium difficile infection (C. diff.), which is a national health concern resulting in more than 500,000 infections and 29,000 deaths annually.

C. diff infection is a debilitating and potentially life-threatening condition that is now recognized as the number one healthcare associated infection in the U.S.,” said Lee Jones, president and CEO of Rebiotix.  “Increasing the awareness of this disease is important.  We applaud both the C Diff Foundation and the State of Minnesota in its effort to build awareness of this significant health concern and welcome the opportunity to be at the forefront of developing a potentially new treatment for patients to address the most challenging of C. diff infections.”

Rebiotix’s first product, RBX2660,  is intended to prevent recurrent C. diff infections. RBX2660 is currently the subject of a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate its efficacy and safety for the prevention of recurrent C. diff infection and is Rebiotix’s most clinically advanced drug product developed from the company’s Microbiota Restoration Therapy™ (MRT) platform.   Rebiotix is also advancing RBX7455, a lyophilized, non-frozen, oral capsule formulation of its MRT technology in an investigator sponsored Phase 1 study for the prevention of recurrent C. diff infection.

“The ability to prevent and potentially eradicate recurrent C. diff infection requires leadership from across the landscape of healthcare, from government institutions to advocacy to academia to emerging biotechnology companies,” said Nancy Caralla, founder of the C Diff Foundation.  “We commend the State of Minnesota and Rebiotix as each seeks to play an important role in reducing the rate and impact of C. diff infection.”

About Clostridium difficile Infection
Clostridium difficile (C. diff.) infection is a serious and potentially fatal gastrointestinal disease, characterized by severe diarrhea, fever, and loss of appetite. It is a leading healthcare-associated infection (HAI), and in the U.S. alone, there are about 500,000 people infected and over 29,000 deaths annually from the disease. Currently, 20-30% of patients with C. diff. go on to experience more than one episode of the disease, which is known as recurrent C. diff. infection. Recurrent C. diff. infection is especially challenging to treat as, to date, there are no approved microbial-based drugs to treat patients with two or more recurrences.

About the C Diff Foundation
The C Diff Foundation, a 501(c) (3)  non-profit organization, established in 2012, and comprised of 100% volunteering professionals dedicated at supporting public health through education and advocating for C. difficile infection (CDI) prevention, treatments, environmental safety, and support worldwide.  The Foundation’s founder is a Nurse and after suffering through C. difficile infections herself and witnessing the loss of her Father, whose life was claimed by C. difficile involvement, the C Diff Foundation came to fruition.  The C Diff Foundation Members, with  their Volunteer Patient Advocates, successfully “Raise C. diff. Awareness”  nationwide and in fifty-six  (56) countries and host a U.S. Nationwide information Hot-Line (1-844-FOR-CDIF) to support health care providers, patients, and families manage through the difficulties of a C. diff. infection among many other programs.

About Rebiotix Inc.
Rebiotix Inc. is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff) infection.  RBX2660 has been granted Fast Track status and Breakthrough Therapy designation from the FDA for its potential to prevent recurrent C. diff. infection. Rebiotix’s clinical pipeline also features RBX7455, a lyophilized non-frozen, oral capsule formulation, which is currently the subject of an investigator-sponsored Phase 1 trial for the prevention of recurrent C. diff. infection.  In addition, Rebiotix is targeting several other disease states with drug products built on its pioneering Microbiota Restoration Therapy (MRT) platform.  MRT 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 via a ready-to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com.

Clostridium difficile in Scotland Have Increased Significantly

Cases of the potentially deadly hospital infection Clostridium difficile in Scotland have increased significantly, figures show. Between April and June, 322 cases of the bug were diagnosed in patients over 65, compared to 270 the previous quarter, Health Protection Scotland (HPS) said the increasing rate was “statistically significant” and in the case of NHS Lothian, specialist support was being given to bring infections down. But the HPS report also found that cases of MRSA had fallen to the lowest ever recorded, with just 27 cases between April and June.

On the issue of C difficile, cases were shown to rising in both older and younger patients. The figures revealed there were 100 new C difficile cases in patients aged 15 to 64 years, compared to 92 the previous quarter. How to Support the ‘Night Owl’ Remote Worker Sponsored by Microsoft 365 [Opt out of Adyoulike ad targeting] HPS said rates for over-65s in NHS Lothian were higher than expected and extra support was being given to tackle the issue. “During this period, NHS Lothian reported an increased incidence of C difficile infection (CDI) to HPS,” the agency said. “HPS are providing on-going support to NHS Lothian in order reduce CDI in the board.” It said no other boards had rates which meant they were a cause for concern in the last quarter. The increasing rate of C difficile in Scotland in the most recent release follow previous reports showing infections falling to record lows following greater efforts to combat bugs and improve hospital cleanliness.

Health Secretary Alex Neil said: “Tackling healthcare associated infections is one of this government’s key priorities and Scotland is widely recognised across the globe as having some of the safest hospitals in the world. “This co-ordinated effort across Scotland’s NHS has had a significant impact on infection rates, with cases of MRSA having reduced by 89.2 per cent and cases of C difficule by 81.9 per cent since national monitoring began. “This quarter we saw cases of MRSA at their lowest levels on record and similarly last quarter C difficile cases were also at their lowest level. “So while we’ve seen increases in the number of cases of                C difficile and MSSA between April and June this year, this should be seen in the context of the dramatic fall in infection rates that have been achieved over the last few years. “

But even these relatively small fluctuations should serve as a clear indication that we must not let up in our drive to tackle this issue. “That is why, working with our key partners, we will continue to monitor infection rates and hospital cleanliness and act immediately where necessary to minimise healthcare associated infections.” The figures comes just over five years since a public inquiry into a deadly outbreak of C difficile at the Vale of Leven Hospital in Dunbartonshire first started, but which has yet to report its findings following a series of delays. Fiona Cameron, Head of Service Infection Prevention & Control, NHS Lothian, said: “NHS Lothian has experienced an increase in the number of cases of Clostridium difficile and we have drafted a robust action plan to identify and eradicate the cause. “As part of that action plan we recently recruited additional infection and prevention control nurses, increased education and ward rounds and began reviewing policies and guidance in relation to the prescription of antibiotic medicine, which is known to be related to Clostridium difficile.

“We have also asked Health Protection Scotland (HPS) to support our work and review our actions to provide any additional input and review actions so far.”

 

Read more at: http://www.scotsman.com/news/cases-of-fatal-hospital-infection-c-difficile-up-1-3561251

Minnesota Has Declared November “C. difficile Infection Awareness Month

 

 

 

 

http://www.clipsyndicate.com/video/play/7172019

According to research, C. Diff is the most common infection in U.S. hospitals within the last decade.

The state of Minnesota has declared November C. difficile Infection Awareness Month.” According to research, C. Diff is the most common infection in U.S. hospitals within the last decade.

Doctors at Mayo Clinic want people to know that they can get the infection even outside of hospitals. They also say once you get it, it’s easier to get it each time.

Dr. Sahil Khanna said ways to prevent C. diff is to wash hands and avoid unnecessary antibiotics.

He said Mayo Clinic is also studying whether or not there could be a vaccination for C. Diff.

“So there’s a large multi-center study that’s going on right now in people who may be at risk for C. Diff infection,” Khanna said. “So if you’ve been to the hospital, if you’ve received antibiotics, those patients can be enrolled in a vaccine study to see if this vaccine would prevent C. Diff from happening.”

Mayo Clinic is also working with Minnesota-based company Rebiotix on another form of treatment for the infection where people can simply ingest a tablet.

“Newer studies are being derived where you can actually take material from donor stool, process donor stool in a lab, and derive all the good bacteria that you need from the donor stool and put them in capsule form,” Khanna said.

Khanna said this capsule-based treatment has more advantages than a colonoscopy-based treatment that is currently being used to treat C. Diff.

 

C. diff. Infections Related to Dental Care and the Unnecessary Use of Antibiotics

During the annual ID Week2017— an annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA) and the Pediatric Infectious Diseases Society (PIDS)— researchers presented findings that suggest that the prevalence of Clostridium difficile is likely caused by the unnecessary prescription of antibiotics by dentists.

“Dentists have been overlooked as a source of antibiotic prescribing, which can potentially delay treatment when doctors are trying to determine what is causing a patient’s illness,” Stacy Holzbauer, DVM, MPH, lead author of the study and career epidemiology field officer for the CDC and MDH, said in a statement. “It’s important to educate dentists about the potential complications of antibiotic prescribing, including C. diff.

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

https://www.rdmag.com/article/2017/10/dentists-overprescribing-antibiotics-overlooked-cause-superbug-infection

“Dentists write more than 24.5 million prescriptions for antibiotics a year,” she added. “It is essential that they be included in efforts to improve antibiotic prescribing.”

C. diff is a deadly bacterial infection that causes severe and possibly fatal diarrhea. Taking antibiotics can put patients at an increased risk for developing the infection.

“Research has shown that reducing outpatient antibiotic prescribing by 10 percent could decrease C. diff rates outside of hospitals by 17 percent,” Holzbauer said. “Limiting the use of inappropriate antibiotics in dentistry could also have a profound impact.”

For the study, the Minnesota Department of Health tracked community-associated C. diff infections—patients who did not have an overnight stay in a hospital or nursing home—in five Minnesota counties.

For the study, the researchers interviewed 1,626 people with community-associated C. diff between 2009 and 2015, 57 percent of which reported they had been prescribed antibiotics.  The researchers also found that patients that were prescribed antibiotics for tended procedures tended to be older and likely received the medication ….   clindamycin.

The six-year study shows that 15 percent of those with the infection had taken antibiotics prescribed to them from dental procedures, one-third of which had a medical chart that did not list dental procedure-related antibiotics, highlighting the apparent disconnect between dental care and medical care.

Another study conducted by the MDH found that 36 percent of dentists prescribed antibiotics in situations that were generally not recommended by the American Dental Association.

“It is possible some dentists aren’t aware of the updated recommendations or are being asked by other healthcare providers to continue preventive antibiotics despite the change,” Holzbauer said.

Rebiotix Features Three Posters Highlighting RBX2660 Clinical and Microbiome Data at ID Week™ 2017 in San Diego, October 4th – 8th

Positive Topline Data from Open-Label Phase 2 Trial of RBX2660 in Recurrent Clostridium
difficile to be Presented for First Time

 

 

 

Rebiotix Inc., a clinical-stage microbiome company focused
on harnessing the power of the human microbiome to treat challenging diseases, today announced that three posters highlighting RBX2660 clinical and microbiome data will be featured at ID Week™ 2017 in San Diego, Oct. 4th to the 8th.

The posters describe clinical findings that highlight the key changes to
the human microbiome profiles of patients who received RBX2660, Rebotix’s Phase 3 drug candidate.

For the first time, researchers will discuss findings from the open-label Phase 2 trial of RBX2660 for the prevention of recurrent Clostridium difficile (C. diff.) infection. Data indicated that RBX2660 was well tolerated and achieved the primary efficacy endpoint of preventing C. diff. recurrence; patients treated with RBX2660 exhibited a treatment success rate of 78.8% compared with a historical control of 51.8% (p<0.0001, N=242). These results demonstrate a 55% reduction in recurrence for those patients treated with RBX2660 compared to the historical controls reflecting standard-of-care antibiotics today.

RBX2660 is currently being evaluated in a multinational Phase 3 clinical trial for the prevention of recurrent C. diff.  Researchers will also be presenting two posters on the microbiome analyses of the Phase 2B  randomized, placebo-controlled, double-blind clinical trial of RBX2660. The analyses, utilizing leading  edge genomic sequencing technology to measure the patient’s microbiome, provide measurable  evidence of RBX2660’s rehabilitative effect on human microbiome profiles of patients who were successfully treated with Rebiotix’s microbiota drug technology.

“The clinical potential of RBX2660 has been highlighted in multiple trials, including our recently
completed open-label Phase 2 study, and the data being presented at ID Week enables us to more fully understand RBX2660’s ability to rehabilitate a dysbiotic intestinal microbiome,” commented Lee Jones, president and CEO of Rebiotix. “These findings are important in that not only can we observe the clinical 2 effect of RB X2660, such as in the open-label Phase 2 study, but by analyzing the microbiota of RBX2660-treated patients, we can see how the microbiome changes in response to RBX2660 treatment and how those changes correlate to treatment success and to the microbiomes of healthy individuals.”

The first poster (#1863; to be presented Friday, Oct. 6th), titled RBX2660 is Safe, Superior to Antibiotic- Treated Controls for Preventing Recurrent Clostridium difficile, and May Rehabilitate Patient Microbiomes:  Open Label Trial Results, reported data from an open-label Phase 2 study of RBX2660 that included 242 subjects. Data from the study indicated that RBX2660’s efficacy in preventing recurrent Clostridium difficile infection (rCDI) was higher (78.8%) than CDI-free rates in the Historical Control Group (51.8%, p<0.0001). The reduction in recurrence of C. diff between these two arms is approximately 55%. Moreover, the safety profile of RBX2660 was consistent with results from previous clinical trials, and microbiota analysis suggested that RBX2660 may rehabilitate patient microbiota as RBX2660-treated subjects’ microbiomes were significantly altered compared to baseline and more closely resembled the RBX2660 microbiome profile than at baseline (p<0.05 by Dirichlet multinomial Wald-type pairwise hypothesis test).

The second poster (#1267; to be presented Saturday, Oct, 7th), titled Successful Response to
Microbiota-Based Drug RBX2660 in Patients with Recurrent Clostridium Difficile Infection is Associated with More Pronounced Alterations in Microbiome Profile, involved an analysis of 58 patients whose stool samples were collected in the randomized Phase 2B clinical trial to determine the effect of RBX2660 on rCDI patient microbiomes. 16s RNA sequencing analyses of patients’ microbiomes indicated that RBX2660 treatment shifted the relative microbiome densities, with taxa-specific increase in Bacteroidia, Clostridia, and decrease in Gamma-proteobacteria abundance. Importantly, a larger shift from baseline microbiome was seen in responders to RBX2600 compared to non-responders, and RBX2660 treatment appears to increase microbiome diversity.

 

The third poster (#1870; to be presented Saturday, Oct. 7th), titled Microbiome Profile is Distinct in Patients with Successful Response to Microbiota-Based Drug RBX2660 Relative to Placebo Responders involved a sub-analysis of 57 patients who participated in the randomized Phase 2B clinical trial of RBX2660. 16s rRNA sequencing analysis was used to compare the microbiome changes from baseline of patients classified as responders to RBX2660 vs placebo. Investigators determined that RBX2660 treatment for rCDI is associated with greater changes in patient microbiomes than placebo treatment. Notably, at 7, 30 and 60 days, microbiomes from RBX2660-treated patients had high Kullback-Leibler divergence from baseline and significantly different means from baseline (p<0.001). Further, active responders trended toward higher Bacteroides and lower Gamma-proteobacteria and Bacilli after treatment, both of which are characteristic of a healthier microbiome. According to the 3 researchers, these changes are consistent with the hypothesis that RBX2660 can restore a healthier microbiome in rCDI patients.

Rebiotix, Inc. funded all three studies.

For More Information About Rebiotix Please

Click On the Following Link:

http://www.rebiotix.com

Ribaxamase Protects the Gut Microbiome and Reduces Risk For New Opportunistic C.diff. Infections According To Phase 2b Study

From IDWeek  2017- SanD iego, CA

 

Ribaxamase is associated with reduced risk for new, opportunistic Clostridium difficile infections (CDI) in hospital patients, according to findings from a multinational, double-blind, placebo-controlled Phase 2b study presented at IDWeek 2017.

 

 

“These data support that ribaxamase can maintain the balance of the gut microbiome and thereby prevent opportunistic infections like CDI during IV beta-lactam treatment,” said lead study author John Kokai-Kun, PhD, of Synthetic Biologics, Inc., Rockville, MD.

“Ribaxamase also protected the diversity of the gut microbiome and reduced the emergence of antibiotic resistance in ceftriaxone-treated patients,” he said.

CDI represent an “urgent threat” but there are no FDA-approved drugs or vaccines to prevent infections, Dr. Kokai-Kun noted.

“SYN-004 (ribaxamase) is a beta-lactamase designed to be orally administered with IV beta-lactam antibiotics and remain localized in the intestine to degrade antibiotics excreted into the intestine,” he said. “This is expected to protect the gut microbiome from disruption thus preventing deleterious effects including, CDI, colonization by opportunistic pathogens and emergence of antibiotic resistance in the gut microbiome.”

“Ribaxamase was well tolerated and not systemically absorbed in Phase 1 studies and efficiently degraded ceftriaxone excreted into the human intestine while not altering the plasma pharmacokinetics of ceftriaxone in Phase 2a studies,” he told the IDWeek audience.

The researchers conducted their study to assess if ribaxamase prevents new-onset CDI. They also assessed non-CDI antibiotic-associated diarrhea, colonization by opportunistic pathogens, gut microbiome alterations and acquired antibiotic resistance.

Data from 412 patients (man age 70 years) in the intention-to-treat population “enriched for higher risk for CDI” were hospitalized for ≥5 days of IV ceftriaxone for treatment lower respiratory tract infections,” Dr. Kokai-Kun said. Patients were randomly assigned 1:1 to receive oral ribaxamase 150mg four times daily or placebo during IV ceftriaxone treatment and for an additional 72 hours.

“Fecal samples were collected at pre-specified points for determination of colonization by opportunistic pathogens and to examine changes in the gut microbiome,” Dr Kokai-Kun said. Patients were monitored for 6 weeks for CDI, defined as diarrhea plus the presence of C. difficile toxin.

Study participants saw a 71% relative risk reduction in CDI (P=0.045) and a statistically significant 44% relative risk reduction in new colonization by vancomycin-resistant enterococci (P=0.0002). Moreover, the respiratory infection was cleared in ~99% of cases demonstrating that concomitant ribaxamase did not impact the cure rate of ceftriaxone.

For continuous infectious disease news coverage from the IDWeek 2017, check back to MPR’s IDWeek page for the latest updates.

Reference: 

Kokai-Kun J, Roberts T, Coughlin O, Whalen H, Le C, Da Costa C, Sliman J. SYN-004 (ribaxamase) prevents New Onset Clostridium difficile Infection by Protecting the Integrity Gut Microbiome in a Phase 2b Study. Poster presented at IDWeek; October 4–8, 2017; San Diego, CA. http://www.idweek.org/.