Clostridium Difficile Infection (CDI), a growing problem worldwide that leads to thousands of fatalities every year can be treated successfully by Fecal Microbial Transplantation (FMT). FMT involves collecting fecal matter from a donor, purifying and mixing with saline solution before placing it in the patient via colonoscopy. As opposed to standard antibiotic therapies which disrupt microflora and sometimes contribute to the recurrence of CDI, FMT restores microbiome and healthy gut function. The research led by Michael Sadowsky, Alex Khoruts, and colleagues at the University of Minnesota in collaboration with the Rob Knight Lab at the University of Colorado, Boulder, suggests that healthy changes to a patient’s microbiome are sustained for up to 21 weeks after transplant, and has implications for the regulation of the treatment.

Sadowsky and his team compared changes in fecal microbial communities of recipients over time to the changes observed within samples from the donor, keeping samples of healthy individuals from the Human Microbiome Project (HMP) as a baseline. They found that the composition of gut microbes in both donor and recipient groups remained within normal range even though they varied over the course of the study.

According to Sadowsky, the findings have important implications for a range of diseases associated with microbial imbalance, or dysbiosis. Furthermore, FMT is currently treated as a drug by the U.S. Food and Drug Administration (USFDA). The dynamic nature of fecal microbiota would push the boundaries of the regulatory regime surrounding FMT that requires a consistent composition. Sadowsky says, “Change in fecal microbial composition is consistent with normal responsiveness to shifts in the diet and other environment factors. Variability should be taken into account when comparing microbial composition in normal individuals to those with dysbiosis characteristic of disease states, especially when assessing clinical interventions and outcomes.”

The research also found that the performance of frozen and fresh preparations of fecal material was indistinguishable. Though there is a need for further study with a larger sample, it does suggest the widespread adoption of FMT. The frozen preparation simplifies the standardization and distribution of the fecal material, facilitates long-term storage of donor material for future study and makes FMT accessible to a greater number of physicians and patients. It is also advantageous over fresh material in the testing of fecal samples for pathogens, which in some cases can take several weeks to complete.

FMT is particularly successful in patients who suffer from recurrent CDI. To further the research, University of Minnesota researchers led by Sadowsky and Dr. Alex Khoruts are currently preparing for a clinical trial using FMT to improve insulin sensitivity in pre-diabetic patients and to treat metabolic syndrome.

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