Clostridium difficile (C. diff) infection is a terrible condition that is acquired in the hospital after taking antibiotics. These antibiotics kill off the good bacteria in a person's digestive tract, and the C. diff begins to flourish, causing serious and life-threatening gastrointestinal issues. An arms race to develop antibiotics to target C. diff has made some forms of the infection drug-resistant to the last line of defense antibiotics that doctors have, but much research has focused on bringing back the bacterial balance in a person's gut to naturally crowd out C. diff.

The normal balance of gut bacteria, or microbiota, keeps a person healthy, and researchers believe that bringing the digestive system's ecology of bacterial players back into balance can solve the issues that the sledgehammer of antibiotics cannot. A small biotechnology company, Rebiotix, has recently been given permission by the U.S. Food and Drug Administration (FDA) to begin Phase II clinical trials on an enema medication that contains a cocktail of bacterial species found commonly in healthy people, and filed an Investigational New Drug application (IND). Data from this company and others has shown that good bacteria can crowd out C. diff and other bad bacteria, without the need of broad spectrum antibiotics.

Antibiotic resistance has been a looming health issue. Patients are increasingly presenting with forms of C. diff that is resistant to the most powerful antibiotics. One way that the medical field and pharmaceutical companies are attempting to deal with the issue is to invest in the development of new and more powerful antibiotics, as a last line of defense when all others fail. Others are taking a similar approach as Rebiotix, which aims to restore the natural balance of the over 2 lbs. of gut bacteria that every adult carries around with him or her each day.

Now, this technology isn't a touchy-feely holistic medical treatment — it's based in hard science and is supported by publications in top tier scientific journals. RBX2660, the code name for Rebiotix's bacterial cocktail medicine, if approved by the FDA, would be the first bacterial treatment for the disease.

C. diff infections affect more than half a million Americans yearly, with 20 to 30 percent of those cases being resistant to first line antibiotic treatment.

Rebiotix also received FDA "fast track" status for its drug in June, which allowed the company to receive a quicker review of its clinical trial data and a quicker route to patients. "IND approval represents a significant milestone for Rebiotix, and continues our progress toward developing and commercializing a new therapy to treat patients with this debilitating and potentially life-threatening disease," said Rebiotix CEO Lee Jones. "We are working quickly to get the clinical trial running and to recruit patients."

Much research is being performed into so called "fecal transplants," which involve giving people ill with a gastrointestinal issue, such as C. diff infection or ulcerative colitis, a slurry of bacteria purified from the fecal matter of healthy individuals. The bacterial cocktail pill that Rebiotix is working on is not derived from fecal material but from bacteria that the company believes to serve as foundations for a healthy human digestive system. This may be the first in a 21st-century wave of probiotics that are FDA-approved for microbiota restoration therapy in ill patients.

For more information about the new clinical trial and possibly becoming involved, visit Rebiotix here.