Don’t Pooh-Pooh Poop:
Fecal Material Transplants Might be the Next Big Thing in Medicine
I first heard about this icky procedure, the Fecal Material Transplant (FMT) in 2013. It is icky but at the same time very interesting and possibilities are limitless. The intention of this article is to inform the general public of Nepal about the possibilities and research that have been conducted around the world and the benefit FMT provided to patients.
FMT involves taking a donor’s feces and placing them inside the colon of the patient. The concept of using Fecal matter as medicine is not new. Fecal suspensions to treat food poisoning and severe diarrhea were first reported in fourth century by a Chinese doctor named Ge Hong. This old technique has gained a new momentum since Max Nieuwdorp and his supervisor used this procedure to cure an 81 year old women who suffered from complications of urinary tract infection. She had bed sores and high fevers and was unable to eat. Doctors treated her with several courses of vancomycin, the standard antibiotic treatment but was of no avail. The normal gut flora (good bacteria) that lives in patient’s colon was out of balance or wiped out by use of antibiotics. An opportunistic bacterium called Clostridium difficile flourished producing toxin that caused terrible diarrhea and bowel inflammation. Nieudorp and his supervisor tried FMT. The duo flushed the contents from the woman’s colon, including, hopefully the C. difficile population and replace it with healthy bacterial flora from from a donor, in this case her son. They mixed the son’s feces with saline in a blender and squirt it straight into patient’s duodenum via a thin tube inserted through her nose. Three days after the treatment, the woman left the hospital walking.
According to Center for Disease Control and Prevention (CDC) published in March 2016 ‘C. difficile’ was estimated to cause almost half a million infections in United States (US) in 2011, and 29 thousand died within 30 days of the initial diagnosis.
To make this FMT therapy accepted by the community of physicians, Nieuwdorp conducted randomized clinical trial. The study was published in the “The New England Journal of Medicine” January 2013. Ninety-four percent of the transplant patients were cured versus 31% for antibiotics.
The human gut microbiome has been described as a “virtual organ”. Conditions ranging from inflammatory bowel diseases and obesity to asthma and cancer have been linked to microbial gut flora. It makes sense to use FMT to replenish normal gut flora that are wiped out by repeated use of antibiotics to fight infection or use of conventional chemotherapy such as an alkylating agent, anthracyclines, antimetabolites to fight cancer. Replenishing the gut flora to its optimum level would mitigate the side effects of medicine as well as treat some diseases. According to ‘clinicaltrials.gov’ as of April 2016, 115 clinical studies are underway (some completed and some recruiting) to understand relationship between gut microbiota and obesity.
In March 2016, the Food and Drug Administration (FDA) issued a proposed update called ‘draft guidance.’ FDA intend to exercise enforcement discretion under limited conditions to treat C. difficile not responding to standard therapies, provided that: 1) the licensed health care provider treating the patient obtains adequate consent from the patient or his/ 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. 2) stool donor and stool are qualified by screening and testing performed under the direction of licensed health care provider for providing the FMT products for treatment of patient.
Currently, the recommended dose of FMT capsule G3 for treatment of recurrent C. difficile is 30 capsules, swallowed consecutively in a single session. Capsules are size 00, approximately the size of a large multivitamin and capsules should be kept frozen until the time of administration.
Now, here lies an opportunity to develop formulations for FMT that are most convenient and cost effective for patients, doctors, and the whole health care system. An elderly patient having to swallow size 00 capsules 30 consecutive times is terrifying. The storage condition required for capsules G3 poses a hurdle in distribution. To solve these problems, efficient enteric coated that are able to withstand room temperature environment for a prolonged period of time would be ideal. Developing enteric coated capsules with new formulation system can offer patients comfort and improve logistic burden.
The other possibility is isolating the bacterial strains and identifying each of bacterial species from fecal microbiota and cultivate in laboratory. Combining all of the bacterial species in proper proportion as it exists in natural proportion and make it to enteric coated capsule would provide approaches to move away from icky material.
In Nepal C. difficile is not as common as in US. However, the use of fecal material transplant in Nepal is not far fetched. As the clinical studies will be completed to understand relationship between gut flora and inflammatory bowel diseases, obesity, asthma and cancer in US and other countries, FMT will become mainstream treatment to cure and mitigate diseases in Nepal as well. The government regulation body, fecal material transplant foundation should be formed in Nepal to regulate and develop policy regarding safe use of fecal material transplant to protect patients and to allow doctors, researchers and scientists to ensure access and facilitate research. Nepali Pharmaceutical companies and research organizations should be ready to take an opportunity to develop efficient FMT products.
The author is Pharmaceutical Technical Manager in MegaNeel LLC, Virginia, US