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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Draft Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile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)
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