Category Archives: Fecal Transplant Treatment (FMT)

UBiome and OpenBiome Partner in Microbiome Studies

The study will provide new insights on mechanics of fecal microbiota transplantation with patients being treated for a C. diff. infection.

uBiome and OpenBiome Partner for Microbiome Study in FMT Patients

Study will provide new insights on mechanics of fecal microbiota transplantation in patients treated for a C. difficile infection.

uBiome and OpenBiome announced a new partnership to study the microbiome of patients undergoing fecal microbiota transplantation (FMT) as a treatment for Clostridium difficile infections (C. diff).

Any patient undergoing clinical FMT treatment can request their complimentary mail-order microbiome testing kit at http://ubiome.com/pages/fmt. The kit allows them to swab a sample of their microbiome, which they send back to uBiome for analysis and sequencing. uBiome will use the collected data to conduct a study of FMT’s impact on the body’s microbiota. All study participants will also receive a detailed report on their personal microbiome.

“Because we will be looking at patients before, during, and after FMT we will be able to learn about how the microbiota adjusts to the treatment,” adds OpenBiome Co-Founder and President Dr. Mark Smith. “This has the potential to not only shed light on C. diff, but also open the door to using FMT with patients suffering other conditions.”

C. diff infections can occur when there is a severe imbalance of gut microbiota. Because of this imbalance, the bacterium thrives and causes extreme gastrointestinal distress.

This study will serve to increase awareness and understanding of how FMT affects the human microbiome, which could increase its acceptance in the medical community as a way to treat a potential variety of gastrointestinal conditions.

About uBiome:
uBiome (ubiome.com) sequences the microbiome for citizen scientists, researchers, and clinicians, using microbial genomics to help patients benefit from new discoveries in scientific research. uBiome conducts research studies on the microbiome and develops clinical diagnostics based on microbiome research.

About OpenBiome:
OpenBiome (openbiome.org) is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation (FMT) therapies. Founded by a team of microbiologists, public health advocates, and concerned citizens, OpenBiome aims to significantly reduce the practical barriers for clinicians providing FMTs, while connecting scientists across studies and disciplines.

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

http://www.prweb.com/releases/2015/07/prweb12820941.htm

June 2015

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

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:

http://cdifffoundation.org/c-diff-radio/

“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:

cdiffFMTimage

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

Recurrent C. difficile Infection; Seres Health Plans To Use Funding To Advance SER-109, Into Phase 3 Clinical Trials

Seres Health, Cambridge, MA based, a contender in the haute field of microbiome therapeutics, just hauled in a $48 million Series C round.

The startup’s developing biologics that target recurrent C.difficile infections.

 

 

The company plans to use the funding to advance its lead candidate, SER-109, into Phase 3 clinical trials. If approved, Seres’ therapeutic line – called Ecobiotic – will be the first oral microbiome-related therapeutic that receives the regulatory go-ahead.

The Ecobiotic system works by “augmenting the biology of the microbiome,” Seres said. In September it released results from its earlier SER-109 trial, in which 29 of the study’s 30 patients were completely cured of their C. dificile infections over the course of 8 weeks. The patients received oral doses of Seres’ microbiome “spores” – that is, precursors to “good” gut bacteria that mature into disease-fighting agents. They’ve been isolated from human fecal matter, then delivered in pill-form to the patient – a promising approach given the growing bacterial resistance to antibiotics.

In addition to treating clostridium-related disease, Seres’ pipeline pursues other as-yet-unnamed indications in the metabolic, inflammatory and infectious disease spaces.

Seres Health was launched in 2012 by Flagship Ventures. This past June, it teamed up with Mayo Clinic for an exclusive research partnership. At the time it also received a $10 million Series B, from investors that include Mayo itself and

Rebiotix, Inc. PUNCH CD 2 Study - Second Clinical Trial Initiated

Update

24 November 2014

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

REBIOTIX, INC.

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.


Caution: New Drug - Limited by Federal (or United States) law to investigational use.

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*