VA trial using the University of Minnesota's donors, finds no reduction in C diff recurrence after FMT (Sep 2024, n=153, UMN) A randomized controlled trial of efficacy and safety of Fecal Microbiota Transplant for preventing recurrent Clostridioides difficile infection FMT 

Fecal Microbiota Transplants
Michael Harrop

Michael Harrop

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This doesn't surprise me at all given that their donors have applied to humanmicrobes.org, so I know their quality very well. From what I recall, I contacted them a few years ago about donor quality and they responded that they already basically use the same criteria that I was suggesting. Based on my screening of their donors, that's completely false.

This is yet another example of huge amounts of time and money being poured down the drain, and patients suffering and dying because of what? Incompetence? Apathy? A competent and motivated researcher would have done everything possible to obtain stool from Human Microbes' donors, so at the very least they could compare its safety and efficacy to their current donors. They would also currently be joining in the effort to make Human Microbes' donors available.

FMT and placebo capsules were manufactured by the Microbiota Therapeutics Program at the University of Minnesota. Microbiota isolated from fecal material obtained from 4 standardized donors was lyophilized using a procedure previously demonstrated to preserve bacterial viability across the taxonomic spectrum. FMT from a single donor was administered via 5 double-encapsulated size 00 enteric capsules with demonstrated acid resistance and delivery efficacy, taken while fasting in one sitting lasting no more than 90 minutes, and containing a total of at >5 x 1011 freeze-dried microbes with trehalose as a cryoprotectant. The dose was chosen as being in line with or modestly higher than that shown by the manufacturer to be effective in a previous publication (See Supplement S2). Stability of FMT over time and across various ranges of shipping temperatures was assessed and viability was confirmed (Supplement S2). Placebo capsules contained trehalose and carboxymethylcellulose and were indistinguishable from active drug.
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Abstract​

Background
Clostridioides difficile infection (CDI) is the most common cause of healthcare–associated infections in US hospitals with 15%-30% of patients experiencing recurrence. The aim of our randomized, double-blind clinical trial was to assess the efficacy of capsule-delivered fecal microbiota transplantation (FMT) versus placebo in reducing recurrent diarrhea and CDI recurrence. The secondary aim was FMT safety assessment.

Methods
Between 2018 and 2022, Veterans across the Veterans Health Administration system with recurrent CDI who responded to antibiotic treatment were randomized in a 1:1 ratio to oral FMT or placebo capsules. Randomization was stratified by number of prior CDI recurrences (1 or ≥2). The primary endpoint was clinical recurrence by day 56, defined as >3 unformed stools daily for ≥2 days with or without laboratory confirmation of C. difficile, or death within 56 days.

Results
The study was stopped due to futility after meeting pre-specified criteria. Of 153 participants (76 FMT, 77 placebo) with an average age of 66.5 years, 25 participants (32.9%) in the FMT arm and 23 (29.9%) in the placebo arm experienced the primary endpoint of diarrhea and possible or definite CDI recurrence or death within 56 days of capsule administration (absolute difference 3.0%; 95% CI [-11.7%, 17.7%]). Stratification by number of recurrences revealed no statistically significant differences. There were no clinically important differences in adverse events.

Conclusions
FMT therapy vs. placebo did not reduce CDI recurrence or death at 56 days. There were no meaningful differences in adverse events between treatment groups.
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