A new study published online in the journal ClinicalInfectious Diseases looked at the use of a non-frozen capsule of microbiome restoration therapy for treating patients with recurrent C. difficile infection.
“Patients with C. difficile are typically managed with antibiotics or fecal transplantation for recurrent C. difficile,” says the study’s author, Sahil Khanna, M.B.B.S., a gastroenterologist at Mayo Clinic. Dr. Khanna says fecal transplantation has been demonstrated to have high success rates by restoring the gut microbiome of patients. However, he says there are several challenges with fecal transplantation including standardization of the product, keeping it frozen, and mitigating the risk of infectious disease transmission during the procedure.
To help reduce the risks, Dr. Khanna and his team studied a transplantation method using a non-frozen capsule instead of whole stool transplantation. An initial dose-finding, the investigator-initiated study looked at the efficacy of different doses of fecal matter and the safety of performing microbiome restoration therapy using an oral product, RBX7455 developed by Rebiotix, Inc. The team found no concerns related to safety.
“Our study has several implications,” says Dr. Khanna. “We think that products like capsules may be able to replace fecal transplantation that is currently done via a colonoscopy. We also think that products that are non-frozen may allow for repeat dosing and for patient-administered self-treatment at home. The good news is that we are moving closer to having safe and effective products to restore the gut microbiome for patients with recurrent C. difficile.”
Dr. Khanna says that larger clinical trials and blinded, placebo-controlled trials are the next step in moving this potential treatment from research into practice.
Even with the world’s most robust infection prevention strategy and protocols, the Mayo Clinic wanted to further reduce its patients’ risk for contracting C.diff and conducted a controlled study to evaluate the effectiveness of Xenex Disinfection Systems’ pulsed xenon ultraviolet (UV) light room disinfection technology. The study, published in the American Journal of Infection Control, found that adding pulsed xenon UV disinfection to the hospital’s disinfection efforts resulted in a 47% reduction in C.diff infection rates on the intervention units that has been sustained for two years. In addition, the facility saw an increase in patient satisfaction scores for environmental cleanliness and a 52% reduction in Vancomycin-resistant enterococci (VRE) infection rates.
Based on the significant C.diff infection rate reductions in the intervention units, the Mayo Clinic expanded pulsed xenon UV room disinfection to 14 additional hospital units with high rates of C.diff infection utilizing 12 robots. This wide-scale implementation resulted in a facility-wide reduction in its Standardized Infection Rate (SIR) from 0.774 to 0.571. SIR rates are used by the Centers for Medicare & Medicaid Services (CMS) to calculate hospital reimbursement.
Many hospital patients, especially those on antibiotics, are susceptible to C.diff, which can live for up to five months on surfaces in the hospital. A person with C.diff may contaminate their hospital room and bathroom, leaving C.diff spores on the walls, handles and other high-touch surfaces. These spores can be easily transferred to the next patient or healthcare worker in that room. For this study, the Mayo Clinic deployed two Xenex LightStrike Germ-Zapping Robots that utilize intense pulsed xenon UV light to quickly destroy pathogens like C.diff and VRE that may be lurking on high-touch surfaces in a room, such as bedrails, tray tables and doorknobs.The robot is easy to use and does not require warm-up or cool-down time, so it’s easily transported from room to room.
In the controlled trial, the first of its kind using pulsed xenon UV disinfection technology, three hospital units (two hematology and bone marrow transplant units and one medical-surgical unit) were designated for pulsed xenon UV intervention, and three units with similar patient populations served as control units. Because of the high C.diff infection rates, all patient rooms on the targeted units were cleaned with bleach daily and at terminal cleaning. In addition to tracking C.diff infection rates, hand hygiene, isolation compliance, and antimicrobial usage were followed on all the units. The only difference in the infection control programs between the controlled units and intervention units was the addition of LightStrike pulsed xenon UV disinfection. LightStrike robots were used after terminal cleaning in 85% of all discharges on the targeted intervention units.
“The Mayo Clinic has a world class infection prevention program that is extremely well-run and well monitored. Their success in reducing C.diff rates is strong evidence that pulsed xenon UV room disinfection can be a very effective tool in a hospital’s infection prevention bundle,” said Dr. Mark Stibich, Chief Scientific Officer at Xenex. “This is very exciting research for several reasons. First, the hospital achieved and sustained lower C.diff rates. Second, hospitals may be confused about the different kinds of UV technologies and their effectiveness, especially after a previous study using mercury UV devices did not show a reduction in C.diff infection rates. This data – and the story of how the Mayo Clinic achieved success in a controlled trial – demonstrates that Xenex’s pulsed xenon UV disinfection technology should be added to the infection prevention bundle as standard of care to enhance patient safety.”
The objective is to conduct a prospective, sham controlled, double-blinded, interventional crossover trial to compare standard terminal cleaning plus PX-UV (intervention) with standard terminal cleaning plus sham PX-UV (control) with crossover at 12 months, following a 6-month washout period. Outcome measures include the rates of HAIs, as well as the recurrence of genetically identical clinical strains of HAIs among patients on study units. The study will be conducted in 2 hospitals covering 16 total hospital units at Detroit Medical Center. Our central hypothesis is that the addition of PX-UV to standard terminal cleaning will be associated with a significant reduction in the rate of HAIs, as well as a reduction in the recovery of genetically identical strains of MDROs. The impact of PX-UV disinfection on rates of HAIs on study units will be determined by comparing rates of HAIs on a) study units where PX-UV is added to standard terminal cleaning practices to b) units where a sham UV disinfection system is added to standard terminal cleaning; and by comparing rates of HAIs on the same medical ward during each of two 12-month phases of a crossover study (one phase when a PX-UV device is added and one when a sham device is added to standard terminal cleaning).
The long-term goal of this project is to establish the efficacy of terminal cleaning plus PX-UV in reducing rates of HAIs due to the following multi-drug resistant organisms (MDROs): C. difficile, vancomycin-resistant enterococci (VRE), Klebsiella pneumoniae and Escherichia coli producing extended-spectrum beta-lactamases (ESBLs), methicillin-resistant Staphylococcus aureus (MRSA) and Acinetobacter baumannii.
At the conclusion of the proposed project, novel data will be generated from this rigorously controlled study regarding the effectiveness of PX-UV in reducing HAIs in a representative, real-world healthcare setting.
To learn more about this Clinical study in progress – please click on the following link to be redirected to clinicaltrials.gov
Rebiotix Treats First Patient in Phase 1 Study of RBX7455, an Orally Delivered Broad-Spectrum Non-Frozen MicrobiotaROSEVILLE, Minn., Jan. 4, 2017
Rebiotix Inc., a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today that the first patient has been treated in a Phase 1 study of RBX7455 for the prevention of recurrent Clostridium difficile (C. diff.) infection.
RBX7455 is a lyophilized non-frozen oral capsule formulation of Rebiotix’s Microbiota Restoration Therapy (MRT), a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format.
RBX7455 lyophilized capsules remove the need for patients to keep the product frozen or refrigerated.
This prospective, single center, two-arm Phase 1 study is a proof of concept dosing study of RBX7455 for the prevention of recurrent C. diff. infection, an increasingly difficult-to-resolve intestinal infection that causes approximately 29,000 deaths in the U.S. each year.1 It is also the first clinical study of an oral microbiota therapy that allows the patient to take the medication at home.
RBX7455 requires no special handling or storage needs for patients. The study will enroll approximately 20 patients at a single U.S. site and is being conducted by the Mayo Clinic, a nonprofit worldwide leader in medical care, research and education.
“New therapies are urgently needed to prevent recurrent C. diff., a debilitating, costly and potentially life-threatening infection,” said Dr. Sahil Khanna, Assistant Professor of Medicine, Department of Gastroenterology and Hepatology, Mayo Clinic, who is leading the study. “RBX7455 not only provides standardized and stabilized human microbes orally, but may provide several advantages in terms of patient dosing and therapy accessibility since no freezing or refrigeration is needed when the patient takes the product home.”
The initiation of the Phase 1 study of RBX7455 enhances Rebiotix’s clinical pipeline of human microbiome-directed drug candidates. The Company’s lead drug candidate, RBX2660, recently completed a Phase 2b randomized, double-blind placebo-controlled trial examining the efficacy and safety of the microbiota restoration therapeutic as a prevention for recurrent C. diff. infection after a standard of care course of antibiotics (PUNCH CD2).
“Dosing the first patient in the Phase 1 study of RBX7455 is a significant milestone for Rebiotix as it solidifies our position as the most clinically advanced microbiome company in the industry, while showcasing the potential of our MRT platform to create new solutions for challenging diseases through standardized microbiota-based drug development,” stated Lee Jones, president and CEO of Rebiotix. ”
RBX7455 is a potentially ground-breaking product for Rebiotix and the entire microbiome industry in that the lyophilized oral capsules do not need to be kept frozen and thus can be stocked in a pharmacy with no special handling or storage needs. As such, RBX7455 offers the unique opportunity to introduce live microbial therapy as a potential treatment for numerous diseases where chronic or repeat dosing is required.”
To read the article in its entirety please click on the following link to be redirected
Fecal microbiota transplants (FMTs) are exactly what they sound like. They involve taking feces from a healthy person and putting them into the body of a sick patient to strengthen the community of bacteria that live in the patient’s gut.
FMTs are very effective at curing stubborn infections with Clostridium difficile (C. diff). The deadly bacteria cause 500,000 illnesses and 14,000 deaths each year in the United States. Small studies have shown that FMTs can cure about 90 percent of serious C. diff infections. They have been so successful that scientists are testing the transplants for other conditions, such as irritable bowel syndrome.
However, FMTs have their downsides. They’re invasive, they can spread disease, and — let’s face it — they’re gross.
What if patients could get the benefits of an FMT without the “ick factor”? A team led by researchers at the Mayo Clinic has developed a delayed-release pill, dubbed SER-109. Research suggests that it may be just as effective as a traditional transplant.
How Does the Pill Work?
In a trial of 15 patients with multiple flare-ups of C. diff infection, SER-109 cured all 15 within eight weeks. At the end of the trial, none of the patients had diarrhea, the hallmark of C. diff infection. All tested negative for the bacteria.
“The results of the study were not surprising and we were expecting a high cure rate,” lead study author Dr. Sahil Khanna of the Mayo Clinic told Healthline. “Previous studies involving conventional fecal transplant from the upper gut have demonstrated good success rates.”
Doctors think that giving patients large doses of antibiotics triggers C. diff infections. Antibiotics destroy the normal, helpful gut bacteria that help the body fight harmful microbes like C. diff. To cure the infection, doctors must reintroduce the good bacteria the patient has lost.
The pill required far fewer live bacteria than a traditional transplant. Even with fewer bacteria to re-seed the patients’ guts, the researchers confirmed that the pill quickly restored bacterial diversity.
Khanna, a gastroenterologist, said that the delayed-release capsules allowed the bacteria to survive the acidity and enzymes in the upper gastrointestinal tract and make it into the patient’s lower gut.
*To read article in its’ entirety click on the link above*
With the cold and FLU season in full swing here are a few natural remedies and some have been shared by the Mayo Clinic. Natural remedies may help ward off or decrease the harsh cold symptoms caused by viruses.
*When cold or FLU symptoms are not relieved by natural alternatives or over-the-counter medications (OTC) or symptoms become worse, please contact a healthcare provider, or Primary Care Physician for medical attention.
Dr. Jay Hoecker, MD, a Mayo Clinic Emeritus consultant, suggests utilizing a Humidifier; Humidifiers add moisture to the air, which helps ease coughing and congestion due to a cold. Warm-mist and cool-mist humidifiers are equally effective in humidifying the air. Also, by the time the water vapor reaches your child’s lower airways, it’s the same temperature regardless of whether it started out warm or cool.
Citrus fruits such as oranges and lemons have been noted as natural immune boosters for the cold and flu due to their vitamin-C content.. Although vitamin C is integral to proper immune function, citrus fruits have a lot more to offer than just one vitamin. Fruits and vegetables have more to offer the immune system than just their vitamins and minerals. The phytonutrients, antioxidants, fibers, oils and acids in fruits and vegetables, which are responsible for their various flavors and colors, are also responsible for their many health, healing and immune- modulating properties.
To make Lemon, Honey and Thyme Sorbet:
Ingredients: 3/4 to 1 cup honey of your choice, 1 cup cold water, small handful of fresh thyme sprigs, zest of 2 lemons, 1-1/2 cups fresh squeezed lemon juice from four lemons.
Combine honey, water, thyme, and lemon zest in a small saucepan, bring to a boil and stir constantly until honey is dissolved. Boil for one minute and remove from heat, set aside until cool. Strain syrup from saucepan into a jug, add lemon juice to the syrup and chill for at least two hours. Pour the mixture into a shallow freezer-proof container (a loaf tin will work fine) and freeze for one hour until the edges begin to freeze. Beat with a hand mixer or whisk until smooth and return to the freezer and repeat these steps two to three times before leaving in the freezer for a final two hours.
It’s very important to stay hydrated during cold and flu season not only to prevent sickness, but to also help recover from any cold symptoms. When feeling ill continually drinking fluids during the course of the day may become decreased. Maintaining hydration can help the recovery process. Staying well hydrated will improve the body’s overall functioning and effectiveness. When dehydrated the recovery process will slow down because the body is struggling to fight off the infection. Staying hydrated can help the respiratory tissue that lines the lungs maintain moisture providing the ability to cough and expel the mucus or blow your nose easier. Warm beverages, such as tea, broth, and soup will also help loosen mucus in the respiratory tracts and aid with congestion. When a cold or FLU caused by a virus causes a fever perspiration and lose of water and electrolytes, especially salt will occur. Electrolytes and water are crucial in keeping the body functioning properly. While drinking plain water is important, gaining back those electrolytes are important too. Many sports drinks (i.e., Gatorade and Powerade) will help to replace the lost electrolytes. For children, Pedialyte is a great option. * Please contact Pediatrician/Physicians to report symptoms and/or seek medical attention if it is not possible to maintain hydration
Try to incorporate both plain water and electrolyte-enhanced drinks if there is a fever, vomiting, or diarrhea. Offer Popsicle s and gelatin during the day along with water and other beverages to help with fluid balance during an illness. Staying proactive with fluid replacement and fluid intake, dehydration can be prevented. If there are any signs of dehydration, act quickly and contact healthcare providers and/or seek medical attention immediately. Maintaining hydration can help fight the FLU and/or common cold symptoms while aiding in the recovery.
Probiotics can boost the immune response to FLU and cold symptoms along with the negative effects that go along with Antibiotic therapies. Powerful strains of probiotics found in yogurt include lactobacillus and bifidobacteria. The more different strains of these bacteria, the better, so look for this information on the label and compare brands when possible. Though store-bought yogurt does contain probiotics, some of these bacteria are inevitably destroyed by the pasteurization process. For a product containing the most live and active cultures, making yogurt at home with raw milk is ideal Kefir is a product very similar to yogurt; it is usually made from milk but can be made with other liquids such as coconut milk or water. Kefir, though, has the advantage of being 99 percent lactose free, making it a good option for those who are lactose intolerant. Additionally, kefir is among the richest sources of probiotics available, with three times the amount of probiotics typically found in yogurt. It can be purchased in most grocery stores. Fermented vegetables are probiotic-rich foods that easily can be made at home. Some common examples that can be purchased at the grocery store include sauerkraut and pickles. Kombucha tea is produced by fermenting sweet black tea with a flat culture of bacteria and yeasts known as the kombucha mushroom.
Elderberry is a fine natural remedy and a statement by Dr. Holly Lucile, ND “There has been a plethora of research on black elderberry mainly on its antiviral and anti-inflammatory activity.”
And the best natural prevention that everyone can do is hand washing (hand hygiene).
CDC’s Slogan: “Hand hygiene saves lives.” Hand hygiene is critical for all of us. It has been identified as the single most effective means of reducing the spread of infection worldwide. Researchers have reported that healthcare associated infections were reduced when hospital personnel washed their hands more frequently. Hand hygiene is a new term to describe hand washing and the hand disinfection process. We pick up “transient flora” when our hands touch objects in the environment. “Resident flora” are organisms that are normally found on the skin on our hands. Hand washing removes the transient bacteria, viruses and decreases the levels of resident flora on the hands decreasing the spreading of germs. By removing the transient flora by hand washing the healthcare associated infections (HAIs) rate decreases. Here’s to sharing the news with others about the importance of hand washing (hand hygiene) and let’s stop giving germs a free ride.
“Here’s to everyone’s good health!”