Fecal transplants have been shown to be an effective and inexpensive treatment for Clostridium difficile infection, but regulatory roadblocks prevent the treatment from becoming mainstream, according to a Wired report.
A Clostridium difficile infection occurs when the naturally occurring bacteria in the large intestine is destroyed, often after antibacterial treatment. A fecal transplant consists of transplanting healthy feces into a person's large intestines to replace the devastated bacteria with healthy ones. Despite recent studies demonstrating the procedure's high success rate, it remains a niche treatment.
In order to become an acceptable, recommended and reimbursable treatment, the procedure has to be tested in randomized, clinical trials. Before the National Institutes of Health can approve a trial, the substance studied — in this case, feces — must be granted "investigational" status by the FDA. These substances fall under the categories of drugs, devices and biological products. The author of the Wired report said feces "simply do not fit into any of those categories."
The report also questions the financial viability of clinical trials, which are often funded by pharmaceutical companies that would not be able to patent or make money off of feces.
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A Clostridium difficile infection occurs when the naturally occurring bacteria in the large intestine is destroyed, often after antibacterial treatment. A fecal transplant consists of transplanting healthy feces into a person's large intestines to replace the devastated bacteria with healthy ones. Despite recent studies demonstrating the procedure's high success rate, it remains a niche treatment.
In order to become an acceptable, recommended and reimbursable treatment, the procedure has to be tested in randomized, clinical trials. Before the National Institutes of Health can approve a trial, the substance studied — in this case, feces — must be granted "investigational" status by the FDA. These substances fall under the categories of drugs, devices and biological products. The author of the Wired report said feces "simply do not fit into any of those categories."
The report also questions the financial viability of clinical trials, which are often funded by pharmaceutical companies that would not be able to patent or make money off of feces.
Related Articles on Gastroenterology:
Half of Colorectal Cancer Cases Could be Prevented by Lifestyle Changes
Everist Genomics Discovers Genes Responsible for Recurrence of Colorectal Cancer
Water Infusion for Cecal Intubation Increases Patient Tolerance, but not Intubation in Unsedated Colonoscopy