Tag Archives: Fecal Microbiota Transplantation

Lee Jones, Rebiotix and Glenn Taylor, Taymount Clinic Discuss Fecal Microbiota Transplant (FMT) AKA Microbiota Restoration Therapy, Research to Clinical, on C diff Radio

cdiffRadioLogoMarch2015Join us on Tuesday, April 7th at 11:00 a.m.  Pacific / 2:00 p.m. Eastern Time

As guests, Ms. Lee Jones, CEO Rebiotix, Inc.  and Glenn Taylor, Microbiologist at Taymount Clinic  discuss

Fecal Microbiota Transplant (FMT) AKA Microbiota Restoration Therapy, Research to Clinical

 

 

Ms. Lee Jones, Founder, President and CEO of Rebiotix Inc, has over thirty years of experience in the medical technology industry in large and small companies and academia. Rebiotix is developing a new category of biologic drugs that use live human-derived organisms to treat disease. Lead candidate RBX2660 (microbiota suspension) is currently undergoing clinical study for recurrent C. diff. infection.

Mr. Glenn Taylor is the Microbiologist at the Taymount Clinic just outside London in the UK. He has spent five years researching the commensal colonization of bacteria in the human digestive system. Listen in as both guests discuss the Fecal or Faecal Microbiota Transplant (FMT),also known as Microbiota Restoration Therapy to treat recurrent C. diff. infections and more – Research to Clinical.

Each C. diff. Spores and More” episode becomes a pod-cast and can be easily accessed through our website:

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C. diff. Spores and More” spotlights world renown topic experts, research scientists, healthcare professionals, organization representatives, C. diff. survivors, board members, and their volunteers who are all creating positive changes in the C. diff. community and more.

Through their interviews, the CDF mission will connect, educate, and empower many in over 180 countries.

Questions received through the show page portal will be reviewed and addressed  by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP,  Dr. Fred Zar is a Professor of Clinical Medicine, Vice HeZarPhotoWebsiteTop (2)ad for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago.  Over the last two decades he has been a pioneer in the study of the treatment of Clostridium difficile disease and the need to stratify patients by disease severity.

 

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C difficile infection; AdvancingBio in Mather, CA Provides a Resource For Healthcare Partners to Treat Patients With Recurrent C. diff. With Fecal Microbiota Transplant

A resource for patients seeking FMT information:

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More than 350,000 cases of Clostridium difficile(C. diff), a dangerous and potentially fatal gastrointestinal bacterial infection, are diagnosed in the United States every year, killing over 15,000 people.

 

AdvancingBio, a not-for-profit organization that offers a treatment to patients suffering from C.diff, announces its launch with the opening of its stool collection and processing facility in Mather, CA, near Sacramento. The facility provides a unique resource for healthcare partners to treat patients with recurrent C. diff using Fecal Microbiota Transplant (FMT).

C. diff is a bacterium that can cause swelling and irritation of the large intestine, or colon. This inflammation, known as colitis, can lead to severe diarrhea, fever and abdominal cramps. The infection is most common in people who are taking antibiotics or have taken them recently, but it also can be transmitted to other people when they come into contact with infected patients or contaminated surfaces, especially if proper hygiene is not practiced.

“There is an emerging need for resources to treat patients suffering from C. difficile, which can be a very aggressive and life-threatening infection,” said Donny Dumani, MD, who oversees all medical aspects of AdvancingBio. “AdvancingBio was created with the mission to provide services to those in need. Our focus is to provide vital resources to healthcare partners who in turn perform fecal microbiota transplants to heal the growing number of patients with C. diff.”

FMT involves the transfer of a healthy microbiome, or the good bacteria present in carefully screened and tested donor stool, including the totality of microorganisms and their collective genetic material. FMT has been shown to deliver a 90+% cure rate.

The donor screening and donation process takes approximately less than 30 minutes. Donors will receive pre-donation educational material and instructions, then proceed to a confidential medical history review by a licensed AdvancingBio staff member. A blood draw will be conducted for infectious disease testing, and then the donor will be provided a clean, private facility for the donation. Eligibility requirements to donate stool are assessed at the time of donation and include feeling well and healthy, being free from cold and flu-like symptoms for 14 days, being between 18 – 65 years old and having a Body Mass Index less than 35.

“The immediate availability of thoroughly screened products that meet the current FDA requirements for our patients with recurring C. difficile is more than welcome,” said R. Erick Pecha, MD, partner at Gastroenterology Medical Clinic in Folsom. “It is long overdue.”

AdvancingBio is open to donors Monday through Friday, from 7:30 a.m. – 1:30 p.m. PT. For more information or to become a donor, please visit advancingbio.org or call (844) 426-7264.

About AdvancingBio
Established in 2015, AdvancingBio is a not-for-profit organization that operates a stool collection and processing facility which provides a unique resource for healthcare partners to treat the growing number of patients suffering from Clostridium difficile infection (C. diff). More than 350,000 cases of C. diff are diagnosed in the U.S. every year, and over 15,000 people die each year from this aggressive bacterial infection. Schedule an appointment or learn more at 844.426.7264 or advancingbio.org

C. diff. and Healthcare-Associated Infections Discussed Live on C. diff. Radio

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#CdiffRadio

C Diff Foundation, Sponsor, with Founder            Nancy C. Caralla, Executive Director and               Dr. Chandrabali Ghose, Chairperson of the Research and Development Community will be broadcasting live on Tuesdays delivering the most up-to-date information pertaining to a leading super-bug/ Healthcare Associated Infection (HAI),  C. difficile, with additional HAI’s, and a variety of related healthcare topics.

Topic experts will be joining your hosts to discuss prevention, treatments, clinical trials, and environmental safety products on a global level.

Tune in Tuesdays beginning March 3rd at 11 AM Pacific Time (2 PM Eastern Time, 7 PM UK) on the VoiceAmerica network  http://www.voiceamerica.com/show/2441/c-diff-spores-and-more

 

Mayo Clinic has developed a delayed-release pill, dubbed SER-109 – benefits of a FMT

* In the news *

http://www.foxnews.com/health/2014/08/26/grossed-out-by-fecal-transplants-now-there-pill-instead/

 

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*

 

 

Fecal Microbiota Transplant – Study Provides Insight Into Structural/Metabolic Changes That Occur After FMT

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Fecal microbiota transplantation

The process of delivering stool bacteria from a healthy donor to a patient suffering from intestinal infection with the bacterium Clostridium difficile  works by restoring healthy bacteria and functioning to the recipient’s gut, according to a study published this week in mBio®, the online open-access journal of the American Society for Microbiology.

The study provides insight into the structural and potential metabolic changes that occur following fecal transplant, says senior author Vincent B. Young, MD, PhD, an associate professor in the Department of Internal Medicine/Infectious Diseases and the Department of Microbiology & Immunology at the University of Michigan in Ann Arbor. The transplants, which have been successful at curing more than 90 percent of recipients, have been used successfully since the 1950s, he says, though it hasn’t been clear how they work to recover gut function.

“The bottom line is fecal transplants work, and not by just supplying a missing bug but a missing function being carried out by multiple organisms in the transplanted feces,” Young says. “By restoring this function, C. difficile isn’t allowed to grow unchecked, and the whole ecosystem is able to recover.”

Young and colleagues used DNA sequencing to study the composition and structure of fecal microbiota (bacteria) in stool samples from 14 patients before and two to four weeks after fecal transplant. In 10 of the patients, researchers also compared stool samples before and after transplant to samples from their donors.

All transplant patients, treated at the Essentia Health Duluth Clinic in Minnesota, had a history of at least two recurrent C. difficile infections following an initial infection and failed antibiotic therapy.

Studying families of bacteria in the samples, investigators found marked differences among donor, pre-transplant and post-transplant samples. However, those from the donors and post-transplant patients were most similar to each other, indicating that the transplants at least partially returned a diverse community of healthy gut bacteria to the recipients. While not as robust as their donors, the bacterial communities in patients after transplant showed a reduced amount of Proteobacteria, which include a variety of infectious agents, and an increased amount of Firmicutes and Bacteroidetes bacteria typically found in healthy individuals, compared to their pre-transplant status.

Then, using a predictive software tool, researchers analyzed the relationship between the community structure of the micoorganisms and their function, presumably involved in maintaining resistance against CDI.

They identified 75 metabolic/functional pathways prevalent in the samples. The samples taken from patients before transplant had decreased levels of several modules related to basic metabolism and production of chemicals like amino acids and carbohydrates, but were enriched in pathways associated with stress response, compared to donor samples or post-transplant samples.

CDI has significantly increased during the past decade, Young says, with previous studies estimating there are more than 500,000 cases of CDI in the United States annually, with health care costs ranging from $1.3 billion to $3.4 billion. Up to 40 percent of patients suffer from recurrence of disease following standard antibiotic treatment. In a healthy person, gut microorganisms limit infections but antibiotics are believed to disrupt the normal structure of these microoganisms, rendering the gut less able to prevent infection with C. difficile.

Further identification of the specific microorganisms and functions that promote resistance of bacterial colonization, or growth, may aid in the development of improved CDI treatments, Young says: “If we can understand the functions that are missing, we can identify supplemental bacteria or chemicals that could be given therapeutically to help restore proper gut function.”

For article in its entirety click on the link below:

http://www.eurekalert.org/pub_releases/2014-06/asfm-ftr061214.php

 

The study was supported by the National Institutes of Health, the Michigan Gastrointestinal Peptide Research Center, and the Essentia Health Foundation in Duluth, Minn.

mBio® is an open access online journal published by the American Society for Microbiology to make microbiology research broadly accessible. The focus of the journal is on rapid publication of cutting-edge research spanning the entire spectrum of microbiology and related fields. It can be found online at http://mbio.asm.org.

The American Society for Microbiology is the largest single life science society, composed of over 39,000 scientists and health professionals. ASM’s mission is to advance the microbiological sciences as a vehicle for understanding life processes and to apply and communicate this knowledge for the improvement of health and environmental and economic well-being worldwide.

 

C. difficile; Fecal Microbiota Transplant (FMT) for C. diff Colitis

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FMT for C diff colitis: How to introduce FMT

Fecal Microbiota Transplantation (FMT), commonly called fecal transplant, is the most effective intervention known for chronically relapsing, antibiotic resistant C diff colitis. There are many ways to introduce donor fecal microbiota to a C diff infected colon. Different methods of performing the transplants include enema, colonoscope, nasogastric tube, and encapsulation.
Two research groups have investigated the most common ways to introduce FMT, and how effective they are compared to each other. The first group was Ethan Gough et al. in the November 2011 article “Systematic Review of Intestinal Microbiota Transplantation (Fecal Bacteriotherapy) for Recurrent Clostridium difficile Infection” published in the journal Clinical Infectious Diseases. Here’s what they found:

• Of 72 C diff colitis patients given FMT by gastroscope or nasojejunal tube, 72.8% were cured without relapsing.
• Of 62 C diff colitis patients given FMT by colonoscope, 83.3% were cured without relapsing.
• Of 156 C diff colitis patients given FMT by enema or rectal catheter, 92.3% were cured without relapsing.

Similarly, Zain Kassam et al., in their April 2013 article “Fecal Microbiota Transplantation for Clostridium difficile Infection: Systematic Review and Meta-Analysis” found that lower GI FMT (enema, rectal catheter, colonoscope) led to a 91.2% resolution rate, while upper GI FMT (gastroscope, naso gastric or nasojejunal tube) led to an 80.6% resolution rate.
Lastly, Canadian infectious disease doctor Thomas Louie presented a poster called “Fecal Microbiome Transplantation (FMT) via oral fecal microbial capsules for recurrent Clostridium difficile infection (rCDI)” at the Infectious Disease Week in October 2013. The poster described preparing a fecal slurry like the type used for enema, colonoscope, or gastroscope instillation, then using serial centrifugation to extract the bacterial portion and triple encapsulating that. At that time, he reported a 27/27 cure rate with no significant side effects. So far in my practice, I have found the encapsulation method to be safe and effective as well.

Dr. Mark Davis, ND, Chairperson Fecal Microbiota Transplant Committee

May 2014

 

 

Seeking Patients Who Have Had Three or More Recurrences With a C. difficile Infection

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3 April 2014

Dr. Tanvi Dhere, MD and Dr. Colleen Kraft, MD at Emory University are currently working with a company testing a set of encapsulated fecal transplants (to swallow) for treatment of recurrent C. difficile infection.  

The first phase (15 patients) has been completed and patients showed a good response.  The delivery is ideal for many patients with C. difficile infection who are elderly and with multiple comorbidities who may have difficulty with colonoscopy.  

We are looking for patients who are on their third or more recurrence of C. difficile infection.

Patients with inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS) are ineligible.

 If you have any potential patients, please have them contact Dr. Colleen Kraft at 404-712-8889 (USA) or email:   colleen.kraft@emory.edu.

*Patients please contact Dr. Colleen Kraft directly via: email for additional information and consideration.  Also,  participants must be willing to travel to Atlanta for 4 study visits

Thank you.

Photo courtesy of E. Ford