When Poop Becomes Medicine!

Authored by: Venkat Rao

I wondered how to phrase the title of this article, because it is not about the well-established fact that regular clearance of the gastrointestinal track is key to maintaining health and wellness. Alternatively, what if poop by itself has medicinal value and helps combat certain types of infections? That seems to be the case going by a recent guideline released by the American Gastroenterological Association (AGA) that recommends use of fecal microbiota-based therapies for adults with recurrent Clostridioides difficile infection (CDI).

CDI is a bacterial infection of the intestine affecting nearly 500,000 patients each year in the US and nearly 30,000 dies from the complications. As a healthcare facility-associated infection, CDI is a significant health security risk in the US with the number of reported cases on the rise. Nearly 35% of the patients suffer from recurrent CDI infections, suffering severe diarrhea, kidney failure, and in some cases leading to death.

Patient fatality with a 30-day mortality rate of 9% is reported among patients 65 years of age and older for healthcare facility related CDI.  With a 30-day mortality rate of 9% among patients 65 years of age and older with hospital associated CDI is the most common healthcare-related infection in the US, adding an additional cost of $4.8 billion annually to the overburdened healthcare system.

Some patients recovering from CDI infection and apparently returning to a normal routine end up with a repeat of the CDI infection, referred  to as recurrent CDI, which is typically reported between 2 to 8 weeks after the first episode.  Recurrent CDI is the relapse of the original infection that creates serious complications with a significantly higher 25% mortality compared to the first bout of CDI and some reports go as high as 36% of mortality among patients with recurrent CDI.

CDI infections occur in most cases among individuals who are in healthcare settings such as hospitals, nursing homes and long-term care facilities. Pathogen spreads upon contact with hands, bedrails, bedside tables, toilets and sinks, telephones, and remote-control units. Basically, the pathogen is highly contagious and transmitted via oral-fecal route. Once infected the bacterium colonizes in the colon and release toxins resulting in severe diarrhea, dehydration, bleeding of the colon, fever, nausea, kidney failure, and mortality of nearly 10 percent of the patients,

The AGA guidelines recommended use of fecal microbiota-based treatment once after completing a standard course of antibiotics to prevent the infection from recurrence in adults with a normal immune system and suffering recurrent CDI.  For those of us with a mild to moderate level of natural immunity, the AGA guidelines recommend use of a microbiota transplant, where healthy human donor stool is transplanted to a recipient in diverse types of forms including capsules containing the donor poop, which are popularly referred to as “poop pills.”

For those with poor immune system, or immunocompromised due to other infections, the guidelines recommend use of any fecal microbiota-based treatment to prevent recurrent CDI. In these cases, a rather unpleasant form of procedure is performed, where stool from healthy donor is delivered through colonoscopy to a patient with recurrent CDI.  Microbiota from the donor stool helps restore the microbiome of the gut and competitively eliminate the pathogen causing recurrent CDI. 

Poop-based treatment is not some experimental endeavors of the academic researchers, it has real commercial ventures attempting to make the treatment less unpleasant—with donor poop going into the gut of a recipient patient—and standardized for consistent efficacy and effectiveness of the treatment.

Seres Therapeutics, a biotechnology company specializing in microbiota-based pharmaceutical products, has a new product called SER-109, derived from human feces from prescreened donors and process the material. Fecal processing is to obtain all spore forms of bacteria and in particular the family of gram-positive bacteria known as Firmicutes, which are natural competitors of C.difficili in the gut. Recently, FDA granted SER-109 license as a breakthrough therapy designation and Orphan Drug designation for the prevention of recurrent CDI.

Likewise, the microbiome company Rebiotix reported positive results from a phase-3 clinical trial of a filtered stool product delivered as an enema to treat recurrent CDI.  Gut microbiota-based therapies are a new and evolving category of pharmaceutical interventions and many more similar products and applications are in the research and development pipeline of biopharmaceutical companies.

The adage, “the more we learn about poop, the better we cab care for ourselves." resonates well with the novel therapy to counter recurrent CDI.