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“C. diff. Spores and More,” Global Broadcasting Network – innovative and educational interactive healthcare talk radio program discusses
This Episode: “EuroBiotix CIC – Supporting Clinicians Within the UK Deliver Fecal Microbiota Transplantation (FMT) To Patients With Recurrent C.difficile Infection”
With Our Guest: James Mcllory
Listen to the PodCast available from the JUNE 7TH C.diff Spores and More episode as we discussed current C.difficile infection objectives for hospitals within the United Kingdom with James McIlroy, a medical student and founder of a not-for-profit stool bank based within the University of Aberdeen in Scotland
MORE ABOUT OUR GUEST:
James McIlroy is a senior medical student at the University of Aberdeen in Scotland. Previously, he earned his Bachelors in Medical Sciences with Honors in human Physiology at the University of Edinburgh. At the present time, James is undertaking a prestigious fellowship at the Royal Society of Edinburgh. During his time at medical school, James identified an unmet need for safe access to fecal microbiota transplantation (FMT) within the United Kingdom. He subsequently established a not-for-profit community interest company called EuroBiotix CIC, which seeks to support clinicians within the UK National Health Service provide FMT.
“C. diff. Spores and More “ Global Broadcasting Network spotlights world renowned topic experts, research scientists, healthcare professionals, organization representatives,C. diff. survivors, board members, and C Diff Foundation volunteers who are all creating positive changes in the C. diff. community worldwide.
Through their interviews, the C Diff Foundation mission will connect, educate, and empower many worldwide.
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 Head 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.
Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive
The US Food and Drug Administration (FDA) on Monday February 29, 2016,announced new draft guidance that aims to further assure that patients infected with the bacterium Clostridium difficile and not responding to standard therapies can access poop transplants, also known as fecal microbiota for transplantation (FMT).
FDA considers FMT an investigational new drug (IND), which requires physicians and scientists to file an IND application if they intend to use the treatment for clinical practice or research.
However, FDA has issued guidance stating that FMT may be used to treat
C. difficile infection not responsive to standard therapies outside of a clinical trial.
The latest draft guidance offers new notice that FDA intends to exercise enforcement discretion regarding the IND requirements for the use of FMT to treat C. difficile infection.
As far as what FDA wants to discuss on this new draft guidance, the agency says it’s requesting comments on which IND requirements are appropriate to waive.
“In particular, FDA is requesting comments on the requirement for institutional review board review of the use of FMT to treat patients with C. difficile infection not responding to standard therapies when the FMT is provided by a stool bank,” FDA says.
The draft guidance comes as over the past few years, FMT, which basically involves the transfer of a healthy donor stool to the bowel of a patient infected with C. difficile, has emerged as an effective means to treat recurrent forms of the bacterial infections, according to a study in the Journal of Law and Biosciences.
Rachel Sachs, an academic fellow at Harvard University’s Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, and an author of that study, explained to Focus that previously FDA said it would regulate FMT like a biologic, but that the decentralized, hospital-based model of FMT envisioned in this new draft guidance more closely resembles the agency’s models for regulating tissue or cord blood products.
Two companies – Rebiotix and Seres Therapeutics – have been granted orphan drug designations for their INDs as FMT treatments for recurrent C. difficile infections, which affect between 85,000 and 110,000 people in the US annually.
And Sachs said she’s under the assumption that once a company gets FDA approval for their FMT product, FDA will revoke its enforcement discretion included in this new guidance.
FDA said Monday it intends to use this discretion for waiving certain IND requirements, provided that:
The licensed health care provider treating the patient obtains consent from the patient or his or her legally authorized representative for the use of FMT products. The consent should include, at a minimum, a statement that the use of FMT products to treat C. difficile is investigational and a discussion of its reasonably foreseeable risks;
The FMT product is not obtained from a stool bank; and
The stool donor and stool are qualified by screening and testing performed under the direction of the licensed health care provider for the purpose of providing the FMT product for treatment of the patient.
And FDA makes clear that an establishment that collects or prepares FMT products “solely under the direction of licensed health care providers for the purpose of treating their patients (e.g., a hospital laboratory) is not considered to be a stool bank under this guidance.”
Sachs co-authored her article with Carolyn Edelstein, director of policy and global partnerships at OpenBiome, a nonprofit stool bank that sells FMT capsules (recommended dose of 30 capsules plus a safety test capsule costs $535, or stool preparations for delivery by colonoscopy, enema, and EGD/naso-enteric tube are $385 each) after conducting first-in-human evaluations (N=4) and a randomized dose-finding study (N=17).
Edelstein told Focus that the draft “suggests that the FDA is seeking to set up a more tailored regulatory scheme, one that considers stool banking separately from small-scale directed donation. We are in favor of seeing stool banking receive more regulatory oversight. We plan to answer the agency’s request for comments on the elements of a regulatory framework that would lend this oversight to the practice of stool banking without unduly burdening the physicians and healthcare facilities using banked material, and by extension, unduly limiting access to the treatment for their patients.”
FDA also explains that there were “difficulties in interpretation” with previous draft guidance, particularly around the provision that the donor be known either to the patient or to the treating licensed health care provider, noting“the revised approach more accurately reflects our intent to mitigate risk, based on the number of patients exposed to a particular donor or manufacturing practice rather than the risk inherent from any one donor.”
But as new FMTs are likely to hit the market as orphan drugs, the bigger issue at play could be associated with cost. Sachs noted that any FDA-approved treatment, particularly since it’s an orphan product, could be expensive (upwards of thousands of dollars for treatment).
C. diff. Global Community Support Program — an extension of our
existing patient program – C. diff. Nationwide Community Support Program.
Our Foundation Members and Medical Advocates, leading the support groups, via: teleconferencing, will now have the ability to offer support to patients, families, clinicians, and individuals seeking support — in the U.S. and 57 countries.
Below you will find the list of countries, with their local cities, able
to participate in our teleconferencing support groups:
Argentina – Buenos Aires and Cordoba
Australia – Adelaide, Brisbane, Melbourne, Perth, Sydney
Austria – Countrywide, Vienna
Bahrain – Countrywide
Belgium – Brussels
Brazil – Belo Horizonte, Curitiba, Rio de Janeiro, Sao Paulo
Bulgaria – Sofia
Canada – Calgary, Edmonton, Halifax, Hamilton, Montreal, Ottawa, Quebec City, Toronto,
Chile – Santiago
China – Beijing
Columbia – Bogota
Costa Rica – National VolP
Croatia – Zagreb
Cyprus – Nicosia
Czech Republic – Prague
Denmark – Countrywide
Dominican Republic – Santo Domingo
El Salvador – San Salvador
Finland – Helsinki
France – Marseille, Paris
Germany – Berlin, Frankfurt, Hamburg, Munich
Greece – Athens
Hong Kong – Countrywide
Hungary – Budapest
India – Bangalore, Delhi, Mumbai
Ireland – Dublin, National VolP
Israel – Jerusalem, Tel Aviv
Italy – Milan, Rome
Japan – Tokyo
Lithuania – Vilnius
Luxembourg – Countrywide
Malaysia – Kuala Lumpur
Malta – Countrywide
Mexico – Guadalajara, Mexico City, Monterrey
Netherlands – Amsterdam
New Zealand – Auckland
Norway – Oslo
Panama – Panama City
Peru – Lima
Poland – Warsaw
Portugal – Countrywide
Puerto Rico – Aguadilla
Romania – Bucharest
Russia – Moscow
Singapore – Singapore
Slovakia – Bratislava
Slovenia – Ljubljana
South Africa – Cape Town, Johannesburg
South Korea – Seoul
Spain – Barcelona, Madrid
Sweden – Malmo, Stockholm
Switzerland – Bern, Geneva, Zurich
Turkey – Istanbul
Ukraine – National VolP
United Kingdom – Birmingham, Edinburgh, Leeds, Liverpool, London, Manchester, National.
Venezuela – Caracas
Registration will remain the same – through the main number (919) 201-1512
or utilizing the nationwide U.S. Hot-Line 1-844-FOR-CDIF, or from the Foundation website http://www.cdifffoundation.org — C. diff. Global Community Support page.
The media and publications are raising
FMT awareness .
The positive effects are being
noted as FMT’s hold a promising treatment option and success is being witnessed in patients suffering
through C. diff. infections.
Being treated by a physician with a Fecal Microbiota Transplantation, to treat recurrent Clostridium difficile infections, is resolving the pain and torment being experienced by patients.
What is a Fecal Microbiota Transplant (FMT)?
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. (1)
However; this treatment – in any form – has not yet been approved by the U.S. Food and Drug Administration (FDA).
Clinical data is pending and FMT remains investigational at this time.
Below is the link to the FDA website and the March 2014 document regarding
Fecal Microbiota Transplantation (FMT) for the general public:
Draft Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies.
III. When FDA Intends to Exercise Enforcement Discretion
FDA does not intend to exercise enforcement discretion for the use of an FMT product when the FMT product is manufactured from the stool of a donor who is not known by either the patient or the licensed health care provider treating the patient, or when the donor and donor stool are not qualified under the direction of the treating licensed health care provider.
FDA will continue to evaluate its enforcement policy.
Furthermore, during the period of enforcement discretion, FDA will continue to work with sponsors who intend to submit INDs for use of FMT to treat C. difficile infection not responding to standard therapies.
This enforcement discretion policy does not extend to other uses of FMT. Data related to the use and study of FMT to treat diseases or conditions other than C. difficile infection are more limited, and study of FMT for these other uses is not included in this enforcement policy. (2)
* Also, click on the link below to view the US Food and Drug Administration (FDA)
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.
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.
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: