This morning, I came across the following article that relates:
FMT has a long history but remains an investigational drug with FDA oversight. In the last few days, the FDA issued a safety warning to physicians reporting that two adults who received FMT developed an even more extensive infection from an antibiotic resistant E. Coli in the FMT they received and one died. Both patients already had compromised immune systems.
One of the more common infections associated with overtreatment is C. difficile colitis, an infection of the large intestine, the colon. It occurs in patients subject to multiple courses of antibiotics, which have significantly altered the bacteria that naturally live within our intestines, the microbiome. The imbalances, think of it as collateral damage to the more beneficial bacteria, have allowed C. difficile to become more prominent. It is debilitating on its own, and a more significant problem in patients already weakened by the issues bringing them to the hospital in the first place.
While initial management has been with even stronger antibiotics, antibiotic resistance to those agents is a growing problem, and effective alternative therapy is to restock the colon with an infusion of bacteria from a healthy individual. For the thoughtful reader who might ask the source of the transplanted bacteria, the answer is that it comes from another person’s feces, collected, homogenized or dehydrated and given as an enema or pill. The medical term is fecal microbiota transplant or FMT.
FMT began as an experiment by clinicians, not in a research laboratory; and how to prepare the transplant material, to screen for donors, and administer the treatment all had to be discovered. Treating patients with FMT was a bit of a cottage industry until it was used enough and was efficacious enough to attract the attention of investment dollars and the FDA.
In the past few years, the FDA has reigned in, and standardized preparations and screening for as part of the workup, you need healthy donors. In the early days, family members could be found to donate, as it is beginning to be commercialized, companies have sought unrelated donors because they can supply the raw materials more consistently. As it turns out, the health and medical history of the donor is more critical than we had thought, and more exacting restrictions need to be applied.
Source: What Pharmaceutical R&D Looks Like