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Frozen, freeze-dried FMT nearly as effective as fresh preparation for treating CDI
Fecal microbiota transplantation was comparably effective for treating recurrent Clostridium difficile infection in fresh or frozen preparations, and lyophilized preparations, while slightly less effective, still cured more than three quarters of patients, according to the results of a double blind randomized controlled trial.
While these three preparations were all delivered by colonoscopy, these findings support the use of orally administered frozen and freeze-dried FMT pills, which would offer more convenience compared with traditional administration of fresh FMT preparations.
Herbert L. DuPont
“This is the first study to show that frozen and freeze-dried microbiota are as good as fresh material, so that we never have to use fresh again,” Herbert L. DuPont, MD, director of the Center for Infectious Diseases at University of Texas Health School of Public Health, said in a press release. “It’s a logistical nightmare to use fresh product. ... Freeze-dried product can be put into a pill that can be given orally, which is much more convenient for patients and physicians.”
From September 2013 to April 2016, DuPont and colleagues randomly assigned 72 patients with at least three episodes of CDI to receive fresh, frozen or lyophilized FMT delivered via colonoscopy. The preparations were sourced from the same eight healthy donors, and included 50 grams of stool per treatment.
The overall CDI cure rate was 87% over 2 months, and cure rates were highest with fresh FMT (100%), followed by frozen (83%) and then lyophilized (78%). Fresh vs. frozen cure rates were statistically comparable, while fresh was statistically superior to lyophilized FMT (P = .022).
Moreover, analysis of 52 patient stool samples before FMT showed significantly lower bacterial diversity and an increased presence of Proteobacteria compared with healthy donor stool, but microbial diversity was restored within a week after FMT in patients who received fresh or frozen preparations. Those who received lyophilized preparations had improved microbial diversity within a week, which fully recovered within a month.
Adverse events were comparable between groups, most commonly including nausea, mild diarrhea and transient abdominal discomfort within 2 days of FMT (86%), and no serious adverse events occurred.
“The study confirms that activity of both frozen and lyophilized fecal product for FMT in patients with recurrent CDI without obvious adverse experiences,” DuPont and colleagues wrote. “We feel that with further study of lyophilized product we will be able to move forward with encapsulation for oral use.”
DuPont is currently testing the safety and efficacy of FMT in pill form, according to the press release. – by Adam Leitenberger
Disclosures: DuPont reports he has served as a consultant to and received research funding from Seres Therapeutics, and received research funding from Rebiotix. Please see the full study for a list of all other researchers’ relevant financial disclosures.