I first heard about this icky procedure, Faecal Material Transplant (FMT), in 2013. It is icky but at the same time very interesting, and the possibilities are limitless. FMT involves taking a donor’s faeces and placing them inside the colon of the patient. The concept of using faecal matter as medicine is not new. Faecal suspensions to treat food poisoning and severe diarrhoea were first reported in the 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 woman who suffered from complications of urinary tract infection. Doctors treated her with several courses of vancomycin, the standard antibiotic treatment, but to no avail. The normal gut flora (good bacteria) that live in a patient’s colon were out of balance or had been wiped out by the use of antibiotics. An opportunistic bacterium called Clostridium difficile flourished, producing toxins that caused terrible diarrhoea and bowel inflammation. Nieuwdorp and his supervisor tried FMT. The duo flushed the contents from the woman’s colon, including, hopefully the C difficile population, and replaced them with healthy bacterial flora from a donor, in this case, her son. They mixed the son’s faeces with saline in a blender and squirted it straight into the patient’s duodenum via a thin tube inserted through her nose. Three days after the treatment, the woman left the hospital walking.

To make this FMT therapy accepted by the community of physicians, Nieuwdorp conducted randomised clinical trials. The study was published in the The New England Journal of Medicine in January 2013. As per the survey, 94 percent of the transplant patients were cured versus 31 percent 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 have been wiped out by repeated use of antibiotics to fight infections or the use of conventional chemotherapy such as an alkylating agent, anthracyclines and antimetabolites to fight cancer. Replenishing gut flora to its optimum level would mitigate the side-effects of medicine besides treating some diseases.

Last March, the US Food and Drug Administration (FDA) issued a proposed update called ‘draft guidance’. The FDA intended to exercise enforcement discretion under limited conditions to treat C difficile not responding to standard therapies, provided that, one, the licensed health care provider treating the patient obtains adequate consent from the patient or his or her legally authorised 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. Two, the stool donor and stool are qualified by screening and testing performed under the direction of a licensed health care provider for providing the FMT products for the treatment of the patient.

Currently, the recommended dose of FMT capsule G3 for the treatment of recurrent C difficile is 30 capsules, swallowed consecutively in a single session. The capsules are size 00, approximately the size of a large multivitamin, and they should be kept frozen until the time of administration.

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 FMT capsule G3 poses a hurdle in distribution. To solve these problems, efficient enteric coated capsules that are able to withstand room temperature environment for a prolonged period of time would be ideal. Developing enteric coated capsules with a new formulation system can offer patients comfort and improve the logistic burden.

The other possibility is isolating the bacterial strains, identifying each of the bacterial species from faecal microbiota and cultivating them in a laboratory. Combining all the bacterial species in the proper proportion as it exists in nature and making them into enteric coated capsules will provide approaches to move away from icky materials.

In Nepal, C difficile is not as common as in the US. However, the use of FMT in Nepal is not farfetched. As clinical studies are completed which will help us to understand the relationship between gut flora and inflammatory bowel diseases, obesity, asthma and cancer in the US and other countries, FMT will become mainstream treatment to cure and mitigate diseases in Nepal too. A government regulatory body, a faecal material transplant foundation, should be formed in Nepal to regulate and develop policy regarding safe use of FMT to protect patients and allow doctors, researchers and scientists to ensure access and facilitate research. Nepali pharmaceutical companies and research organisations should be ready to take an opportunity to develop efficient FMT products.

Shrestha is the pharmaceutical technical manager at MegaNeel LLC, Virginia, US