Clostridium difficile, or C. diff, is one of the most common hospital acquired infections (HAI). It spreads easily and recurs in about 20% of patients. The C. diff bacterium inflames the colon (a condition known as colitis), and usually takes hold because patients on antibiotics cannot fight off the bacterium.

We have discussed the seriousness of C. diff before, and reported on clinical trials for a prophylactic therapy called SYN-004. Until that drug is approved, however, people with C. diff infections have few options to help them. OpenBiome is hoping to change that by granting patients with C. diff, as well as other diseases and infections such as Crohn’s and ulcerative colitis, access to a healthier and safer life.

How do fecal microbiota transplants work?

Fecal microbiota transplantation (FMT) takes a sample of healthy stool and transplants it into the colon of a patient with C. diff. The microbes in the healthy stool will settle into a patient’s gut and eventually replace the infected and unhealthy bacteria. A small 2013 study by the New England Journal of Medicine tested fecal transplantation on patients with recurring C. diff infections. Their results show that FMT was successful in curing 94% of those patients, and most of them (81%) needed only one treatment. A success rate of more than 90% is virtually unheard of in the medical field.

Why OpenBiome is worth discussing

OpenBiome and companies like it allow C. diff patients, as well as those suffering from other inflammation conditions, access (through participating clinics) to a treatment for approximately $250. They are even developing a capsule for oral use, as most people (it is assumed) are more comfortable with taking a pill than using a stool sample in an enema. Furthermore, because Open Biome screens its samples, patients may have a decreased risk in contracting another infection or disease – a risk they may not be able to eliminate if they choose their own donor.

The problem is that FMT has not been approved by the Food and Drug Administration for its use in anything but C. diff. Because stool is technically considered a drug (as opposed to tissue), it falls under the same regulatory guidelines as any other drug, which means it is not approved for use in patients with auto-immune diseases like Crohn’s or conditions like irritable bowel syndrome. Therefore, OpenBiome could be shut down for dispensing unregulated, and technically illegal, drugs to patients.

Cases like these are particularly interesting: on the one hand, FMT has had almost miraculous results (from a medical perspective) helping people with HAIs like C. diff and with chronic inflammation conditions. On the other hand, patients should demand that their medications are FDA approved – and FMT has not been around long enough to really study any potential side effects. We simply do not know what might happen down the line to people who use FMT for something other than C. diff.

For more information about fecal microbiota transplantation, we encourage you to read the full stories and websites including in this blog. We also invite you to visit Plaxen & Adler, P.A. to discuss the benefits and dangers of experimental drugs and treatment processes with our attorneys.