Fecal Transplants Bring Hope to Patients, Challenge the FDA

Janis C. Kelly


December 15, 2014

In This Article

A Surprisingly Effective Treatment

At first glance, fecal microbiota transplant (FMT) appears more like gardening than clinical medicine, involving as it does the "replanting" of normal microorganisms into the gastrointestinal tract. However, FMT's nearly 90% cure rate for patients with recurrent Clostridium difficile infection (CDI) verifies its surprising new role in contemporary gastroenterology—namely, as the most effective treatment available for this indication, far surpassing that of antibiotics. The success of FMT has catalyzed a surge of new approaches to replacing gut microbes and a dramatic revision to the US Food and Drug Administration's (FDA) initial regulatory approach.

FMT is defined as "infusion of a fecal suspension from a healthy individual into the gastrointestinal tract of another person to cure a specific disease."[1] The procedure can be done using fresh stool transplants, frozen stool transplants (capsules are a subtype), or biosynthetic combinations of organisms derived from normal fecal microbiota. The regulatory environment for these approaches is still unsettled and has been further roiled by the ease with which FMT can be self-administered by patients at home.


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