February 16, 2017
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Freeze-dried FMT capsules effectively treat recurrent C. difficile infection

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Freeze-dried, encapsulated fecal microbiota was safe and highly effective for the treatment of recurrent Clostridium difficile infection after a single treatment, according to recent study results.

“The development of stable, encapsulated, freeze-dried fecal microbiota has proven to be a successful technology to treat recurrent Clostridium difficile infection via fecal microbiota transplantation (FMT),” Michael J. Sadowsky, PhD, director of the BioTechnology Institute and Distinguished McKnight Professor at the University of Minnesota, told Healio Gastroenterology. “The use of encapsulated microbiota will allow FMT to become more amendable to mainstream medicine and allow for the possibility of multiple administrations, prophylactic use for at-risk patients, or treatment of individuals where colonoscopy is not an alternative.”

Michael J. Sadowsky, PhD

Michael J. Sadowsky

Sadowsky and colleagues developed a lyophilization process to preserve the microbial viability and diversity of FMT donor material, and to enable consistent encapsulation. Then from June 2014 to March 2016 they used the resulting FMT capsules across a range of doses to treat 49 patients with recurrent CDI for whom antibiotics had failed.

The researchers successfully treated 87.8% of the patients, with no CDI recurrence over 2 months. Among the 39 patients who had not received a previous FMT, the success rate was 89.7%.

Further, the 30 patients treated with the lowest dose and the simplest protocol without a colon purgative had a 93.3% success rate, and among the 25 of them who had not received a previous FMT, the success rate was 96.2%.

No serious adverse events occurred except one patient was hospitalized for a complex urinary tract infection and had a subsequent recurrence of CDI.

Finally, analysis of the patients’ fecal microbiomes showed their microbial communities were almost normalized within a month after treatment, which was “somewhat delayed relative to what was seen with colonoscopically administered FMT,” Sadowsky and colleagues noted. “However, this difference does not appear to impair clinical response with respect to prevention of CDI recurrence.” – by Adam Leitenberger

Disclosures: Sadowsky reports he consulted for and received research grant support from CIPAC Limited, and consulted for Crestovo. Please see the full study for a list of all other researchers’ relevant financial disclosures.