Scientists are seeking to make poop an easy pill to swallow.
Once viewed by many physicians as a controversial treatment, fecal transplantation (though it is still classified by the U.S. Food and Drug Administration as “investigational”) is an effective method to treat a nasty — and sometimes deadly — infection called Clostridium difficile (C. diff). Doctors perform the procedure by collecting stool from a tested donor and pumping it into an infected patient, typically via colonoscopy.
Now, scientists are determining if bacteria extracted from human stool could be effective to cure C. diff when condensed into a pill. They also want to know whether these so-called “crapsules” (as GI doctors like to joke) could be used to treat trickier bowel illnesses, like Crohn’s disease and ulcerative colitis. At Drexel, one of those studies will be underway in 2017.
C. diff strikes patients by tampering with the “beautiful ecosystem” of your gut’s “good” and “bad” bacteria, according to Neilanjan Nandi, MD, a gastroenterologist and assistant professor at Drexel University College of Medicine. He offers fecal transplants — technically known as Fecal Microbiota Transplantation (FMT) — to patients who have had three or more relapses of the infection.
The human digestive tract contains as many as 1,500 different species of bacteria. While most of them are helpful or harmless, an imbalance of these organisms can cause otherwise nontoxic bacteria to multiply and make you sick. Patients can become infected with C. diff if they have received long-term treatment with antibiotics, which can kill off too much “good” bacteria. A recent study found that the bug can also be passed on in hospitals even by patients who do not have any symptoms.
Fecal transplants work by repopulating a patient’s gut microbiome — a person’s collection of genomes and microbes — with a diverse set of microorganisms.
“If you have a healthy person with healthy stool and a nice, normal balance of flora, that’s probably the most elegant and ultra probiotic there could possibly be,” Nandi said.
Now that fecal transplants are becoming more widely accepted, startups in the microbiome space are scrambling to design new routes of administering poop to patient.
In July, a company called Seres Therapeutics, Inc. halted clinical studies on its new poop pill after nearly half of patients had their C. diff infections return. Nandi, who was running a trial on the pill at Drexel, says it is too early without data analysis to speculate on why the study failed to meet its expected results. However, he thinks testing encapsulated pills is positive for research and could lead to new treatments for patients who don’t respond well to other methods.
Nandi is now gearing up to test another Seres investigational medicine — SER-287 — for adults with mild-to-moderate ulcerative colitis (UC). He will begin recruiting patients sometime in early 2017.
SER-287 pills contain bacterial spores highly purified from stool donations. In this phase 1b clinical trial, Drexel and other sites around the country will evaluate the pill’s safety and efficacy versus placebo in a randomized, double-blind fashion to treat mild-to-moderate ulcerative colitis.
Unlike C. diff however, Crohn’s and colitis are caused by more than just an imbalance of microorganisms in the gut. Immune system deficiencies and genetic mutations also play a role —making these diseases especially hard to fix. Treating patients with different types of inflammatory bowel disease is a process of trial-and-error, and the medications available do not work at all for certain patients.
“Antibody drugs need to be administered intravenously [through an IV] or subcutaneously [an injection] to get into your blood circulation, in order to quiet down the overactive immune system,” Nandi said. “These antibody drugs don’t get absorbed by your intestine, because they’re too large. You can swallow them, but you’ll poop them right out.”
While a pill filled with poop may seem initially unlikely to cure ulcerative colitis, Nandi thinks it’s possible to modulate the disease and bring about meaningful clinical remission. And since the only medications currently available to treat IBD are administered through injections or IV, having an encapsulated drug that patients could take orally would be a real game changer.
“In the future, a combination of immune system medications and/or orally administered bacterial spores may be more beneficial to some patients rather than either therapy alone,” he added.
The SER-287 trial is the first step to one day giving patients more options and better outcomes, he explained.
In that vein, Nandi will lead yet another clinical trial at Drexel in 2017 to test the drug Mongersen for patients who have Crohn’s disease. This encapsulated pill works by inhibiting the production of a pro-inflammatory protein.
“Every IBD patient is different,” he said. “Everybody needs a different mechanism to control their disease. And if that’s the case, then we need to continue to strive to find new treatments and new ways to administer them.”