Some hospital-acquired infections are hard to beat. But a Minnesota startup, MikrobEX, is attempting to battle a particularly nasty one called C. difficile with an unusual weapon: stool.
Serial entrepreneur and MikrobEX cofounder Mike Berman is determined to help people look beyond the ick factor and recognize the life-saving properties of stool. The company is developing a stool bank (yes, you read that right) to provide the healthy bacteria needed to eliminate an infection of the gastrointestinal tract when exposed to the C. difficile bacteria.
Hospitals administer a prophylactic antibiotic to patients to prevent wound site infection, but the side effect of that medication is that it wipes out bacteria in the GI tract. Some of these patients then acquire the so-called C.difficile infection, and while for the majority the infection goes away when you stop taking the antibiotic or switching to another one, roughly 25 percent experience severe symptoms, including diarrhea.
“There is a pool of patients that have a very difficult course where they are on antibiotics for months to get rid of it,” Berman says. ‘”The death rate is 5 percent.”
The best treatment, though not often performed, is what is known as a fecal transplant, Berman says. Stool from a healthy patient, which has been processed to remove all nonbacterial elements, is introduced into the gastrointestinal tract of the patient using a tube passed through the nose, or a colonoscopy such that the full spectrum of healthy bacteria can be reintroduced.
The problem is that hospitals don’t want to deal with the elaborate procedures required to perform a fecal transplant. An apt analogy would be what hospitals would have to do if blood banks didn’t exist and hospitals would need to do blood transfusions, Berman said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“Hospitals would have to go find a donor, screen the blood, store the blood, package it,” Berman said. “It would be an infrequently done procedure.”
Enter MikrobEX. Berman and two cofounders are trying to develop a system where they would collect and process the stool from healthy people. The processed stool would be frozen and put inside a capsule where the casing would be gastro-resistant. All the patient would have to do is swallow the capsule like it were a tablet and the capsule would pass through the body and only open in the small intestine, where it would deliver the full spectrum of healthy bacteria into the gastrointestinal tract.
All hospitals would need to do is simply order the product from MikrobEX and stock it appropriately, Berman explains. A similar approach is being pursued in Britain where a patient’s own stool prior to medical treatment is stored such that it may be reintroduced in the body if he or she falls prey to C.difficile infection, according to Wikipedia.
MikrobEX is in its infancy. The company has cleverly raised $4 million in October to land another $1 million in 2012. The money will be used to further develop the product and gain approval in the European Union, Berman said.
[Photo Credit: Freedigitalphotos user Michael Marcol]
