Tag Archives: gut health

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.

C Diff Foundation Celebrates National Volunteer Week 2017

National Volunteer Week, April 23 – 29th

The C Diff Foundation celebrates National Volunteer Week, April 23 – 29 to recognize more than 150 members of the C Diff Foundation Volunteer Members, including Volunteer Patient Advocates, have collectively donated more than 20,000 hours of volunteer service to the Foundation last year. The theme for this year’s celebration is “Sharing Time, Touching Lives.”

“Through the years the C Diff Foundation Volunteer Members have served as ambassadors of goodwill, service and compassion,” said Angelo Ortiz, C Diff Foundation’s Treasurer and Chairperson of  the Volunteer Patient Advocate Program

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

Not only do the volunteer members provide financial support for the C Diff Foundation’s programs — it is through their dedication and passion that continuously expands the Foundation’s mission.  Some volunteer patient advocates have their own unique C. diff. Survivor Journey which is shared with compassion, dedication, and caring hearts touching patients, students, fellow healthcare professionals,  and residents in the community every day.

Volunteer members will be recognized on November 9th & 10th  during the C Diff Foundation’s
5th Annual International C. diff. Awareness Conference and Health EXPO being hosted
in Las Vegas, NV.  During the annual event the “Volunteer Shooting Star” awards will
be presented along with numerous Volunteer Patient Advocate certificates for service hours.

“We are fortunate to have such kind and giving volunteers,” said Nancy C. Caralla, Foundress and Executive Director of the C Diff Foundation, “It is an honor to recognize those who have selflessly given so much to help educate, and promote the Foundation’s mission worldwide.”

The C Diff Foundation Volunteer Program was organized in 2012 to provide volunteer services, promote community understanding of Clostridium difficile (C. diff.) CDI  Infection Prevention, Treatments, Environmental Safety and Support and to raise funds for special C Diff Foundation patient/family programs.

The C Diff Foundation Members, with  the Volunteer Patient Advocates, successfully promote
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 guiding them through the difficulties caused by a C. diff. infection.

Volunteers Members serve in 12 different committees;  Volunteers host monthly teleconference support sessions; Provide Education about C. diff. infection and other linked healthcare topics through workshops, community events, and literature with patients, their families, and residents from villages to cities around the globe; Triage Nurses assist patients, families, clinicians with answers to prevention, treatment, environmental safety and support questions Monday – Friday 9:00 a.m. – 5:00 p.m. EST;  Register support session participants,; Provide IT management; Give clerical and social media assistance to various departments;  Provide a “Global Broadcasting Network” with www.cdiffradio.com with their educational radio
program,C. diff. Spores and More which broadcasts live every Tuesday at 1:00 p.m. EST. We are grateful for our sponsor Clorox Healthcare for making this program possible.  Each episode becomes a podcast and is accessible from the C. diff. Spores and More living library located on the main cdiffradio.com program page. Each November the Volunteer Members gather at the annual conference to both present and provide assistance in making the attendees feel welcome and expand their knowledge base on a variety of health topics that are linked to the main topic ~ Clostridium difficile infections.

For more information about the C Diff Foundation Volunteer Program, please call 919-201-1512 (toll free in USA 1-844-367-2343 ) or e-mail:   info@cdifffoundation.org

 

C Diff Foundation Volunteers — Helping Us  Help Others and The Beacon Of Light On the Other Side Of Pain and Suffering.

 

 

 

U.S. Food and Drug Administration (FDA) Has Approved Merck’s (MSD) ZINPLAVA ™ (bezlotoxumab) Injection 25mg/ml To Reduce Recurrence Of Clostridium difficile Infection In Patients 18 Years Of Age Or Older

MERCKBW2015_medLogoBLK [Converted] (2)

Merck  known as MSD outside the United States and Canada, on October 22, 2016 announced that the U.S. Food and Drug Administration (FDA) has approved ZINPLAVA™ (bezlotoxumab) Injection 25 mg/mL.

Merck anticipates making ZINPLAVA available in first quarter 2017.

ZINPLAVA is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence.

ZINPLAVA is not indicated for the treatment of CDI.

ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.

Please see Prescribing Information for ZINPLAVA (bezlotoxumab) at http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf 

 

Patient Information for ZINPLAVA at http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_ppi.pdf

CDI is caused by bacteria that produce toxins, including toxin B. Symptoms of CDI include mild-to-severe diarrhea, abdominal pain and fever. The incidence of recurrent CDI is higher in certain patient populations, including people 65 years of age or older and those with compromised immune systems.

“For generations, Merck has been steadfast in its commitment to fighting infectious diseases – and that commitment continues today. ZINPLAVA is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects,” said Dr. Nicholas Kartsonis, vice president of clinical development, infectious diseases, Merck Research Laboratories.

Selected safety information about ZINPLAVA

Heart failure was reported more commonly in the two Phase 3 clinical trials in ZINPLAVA-treated patients compared to placebo-treated patients. These adverse reactions occurred primarily in patients with underlying congestive heart failure (CHF). In patients with a history of CHF, 12.7% (15/118) of ZINPLAVA-treated patients and 4.8% (5/104) of placebo-treated patients had the serious adverse reaction of heart failure during the 12-week study period. Additionally, in patients with a history of CHF, there were more deaths in ZINPLAVA-treated patients [19.5% (23/118)] than in placebo-treated patients [12.5% (13/104)] during the 12-week study period. The causes of death varied, and included cardiac failure, infections, and respiratory failure. In patients with a history of CHF, ZINPLAVA (bezlotoxumab) should be reserved for use when the benefit outweighs the risk.

The most common adverse reactions occurring within 4 weeks of infusion with a frequency greater than placebo and reported in ≥4% of patients treated with ZINPLAVA and Standard of Care (SoC) antibacterial drug therapy vs placebo and SoC antibacterial drug therapy included nausea (7% vs 5%), pyrexia (5% vs 3%) and headache (4% vs 3%).

Serious adverse reactions occurring within 12 weeks following infusion were reported in 29% of ZINPLAVA-treated patients and 33% of placebo-treated patients. Heart failure was reported as a serious adverse reaction in 2.3% of ZINPLAVA-treated patients and 1.0% of placebo-treated patients.

In ZINPLAVA-treated patients, 10% experienced one or more infusion specific adverse reactions compared to 8% of placebo-treated patients, on the day of or the day after, the infusion. Infusion specific adverse reactions reported in ≥0.5% of patients receiving ZINPLAVA and at a frequency greater than placebo were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%), headache (2%), dyspnea (1%) and hypertension (1%). Of these patients, 78% experienced mild adverse reactions, and 20% of patients experienced moderate adverse reactions. These reactions resolved within 24 hours following onset.

As with all therapeutic proteins, there is a potential for immunogenicity following administration of ZINPLAVA. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to bezlotoxumab in two Phase 3 studies with the incidence of antibodies in other studies or to other products may be misleading. Following treatment with ZINPLAVA in these two studies, none of the 710 evaluable patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.

About bezlotoxumab

Bezlotoxumab was developed by researchers at the University of Massachusetts Medical School’s MassBiologics Laboratory in conjunction with Medarex (now part of Bristol-Myers Squibb), and was licensed to Merck in 2009.

Please see Prescribing Information for ZINPLAVA (bezlotoxumab) at http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf 

 

About Merck

For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships.

For more information, visit www.merck.com

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

http://www.pharmiweb.com/PressReleases/pressrel.asp?ROW_ID=187373#.WAsjR8li9kk

 

*Please note – The C Diff Foundation does not endorse any product and/or clinical study in progress. All website postings are strictly for informational purposes only.

Hydrating Watermelon Drink by Michele Martello, Wellness Advocate

 

Ingredients Used in this video:

Seedless Watermelon

Water infused with fruit

Splash of Coconut Water

Fresh Mint

Ice

Equipment:   Blender

 

Created by Michele Martello, Wellness Advocate for the C Diff Foundation

July 2016

Signs That Tell If You Are Dehydrated

waterDrinking

With the summer season at its peak and heat indexes climbing each day topped by a diagnosis of a C. difficile infection, dehydration can occur quickly.

Here is a short list of major signs to watch for that will indicate the body is low on fluid and prompt attention is needed to gain proper hydration.  Dehydration is dangerous and can even be life-threatening.

**  When any one is unable to maintain adequate hydration due to vomiting, diarrhea, excessive perspiring, over-exposure in hot weather — seek medical attention as soon as possible.

 

Signs of Dehydration (1)

Muscle Cramping:  The hotter you get, the more likely you are to get muscle cramps, and that’s from a pure heat effect on the muscles. As the muscles work harder and harder, they can seize up from the heat itself. Changes in the electrolytes, changes in the sodium and potassium can lead to muscle cramping.

Fever and Chills

Food Cravings: especially something sweet due to the inability for the liver to release glycogen.  Craving something sweet? Reach for a snack that has high water content. Most fruits and vegetables have high water content and will help maintain hydration.

How to Check If You’re Dehydrated

Here are two other ways to check if your body is dehydrated.

  • Try this skin test. First, use two fingers to grab a roll of skin on the back of your hand (between where your watch sits and where your fingers start), advises Higgins. Pull the skin up about ½ to one centimeter high and then let the skin go. The skin should spring back to its normal position in less than a couple of seconds. Higgins says that if the skin bounces back slowly, you might be dehydrated.
  • Check your urine. If you’re well-hydrated your urine will be mostly clear with a tinge of yellow, Higgins explains. Yellow, chardonnay, and orange are the “warning” colors to watch for. When your body is about three percent dehydrated your urine will be noticeably yellow. When your body is about five percent dehydrated, your urine will appear chardonnay-colored. When your body is more than five percent dehydrated – which is considered severely dehydrated – your urine will appear orange.

Tips for Staying Hydrated

  • Keep your water bottle handy and sip throughout the day.
  • Spice up plain water. Add a splash of fruit juice or chunks of fresh or frozen fruit,
  • Try different teas. unsweetened decaffeinated flavored teas, which are available in lots of different flavors, they all count towards your daily fluid goal.
  • Makeover your snacks. Refrain from dry, carb snacks like chips, pretzels, and crackers which have a very low water content, reach for fresh or frozen fruit, yogurt, healthy smoothies, celery with peanut butter, and cut veggies with hummus,
  • Pile on the produce. Set a goal to make half of the meals plated with produce.  Vegetable and fruit servings will supply water as well as a hearty dose of vitamins, minerals.
  • Room temperature or temped water/beverages. When it comes to fluids, refrain from ingesting  fluids with extreme cold temperatures. When ice water comes into the stomach it constricts the arteries surrounding the stomach, which help the stomach function properly and help with water absorption and Ice water will just sit in the stomach until it warms up. If you hear water swishing around in your stomach, it means the water is not getting absorbed. Fluids that are cool or room temperature are better options.
  • Refrain from alcoholic beverages and high caffeinated drinks.

What is the daily total water intake, which includes water gained from foods and other beverages like tea and milk?  The Institute of Medicine recommends that most women get about 2.7 liters of water a day (or about 12 cups), and most men get about 3.7 liters a day (or about 15 cups).

  • Always discuss fluid intake with healthcare providers as cardiac and kidney conditions may alter the amount of fluids allowed on a daily basis.   When in doubt, contact a healthcare provider or visit a local clinic/hospital for complete assessment.  Stay Safe!

(1) http://www.everydayhealth.com/news/unusual-signs-of-dehydration/