1. A frozen fecal microbiotia transplant was effective in resolving diarrhea in individuals with refractory or recurrent Clostridium difficile infection.
2. The frozen fecal microbiota transplant was safe, as no serious adverse events were observed in the 20-person test group.
Evidence Rating Level: 2 (Good)
Study Rundown: Despite treatment with antibiotics, Clostridium difficile infections (CDIs) can often relapse and recur and result in significant morbidity and mortality. Fecal microbiota transplant (FMT) has been shown to be effective in treating CDI, however there are currently concerns about safety. This study reports on frozen FMTs to 20 individuals between 7-90 years old with refractory or recurrent CDI as defined by the FMT Working Group consensus guidelines. 70% of recipients improved after the first dose and remained asymptomatic for 8 weeks. All 6 non-responders underwent re-treatment and 5 had resolution of diarrhea, and 4 of those remained asymptomatic for 8 weeks. The overall response rate was 90% with no serious adverse events observed.
Strengths of this study include the careful screening of recipients and donors and the protocol used to prepare the FMT capsules. Weaknesses of this study include the small sample size and the absence of a control group. Additionally, all participants were treated at one tertiary center and the protocol used may not be feasible in some settings. Nevertheless, the promising results of this pilot study will help support the execution of larger studies that can further investigate the safety and efficacy of this intervention.
Relevant Reading: Clostridium difficile infection: a worldwide disease
In-Depth [open label study]: This study administered frozen FMTs in the form of capsules from a donors. Donors were healthy adults 18-50 years of age who underwent detailed health screening as well as screening tests for enteric pathogens, hepatitis A, B, and C, HIV, and syphilis. Donated stool was frozen for 4 weeks after collection to allow for retesting for HIV and hepatitis B and C before transplantation. Donated stool was administered in capsules orally on two consecutive days. Each recipient received stool from one donor and recipients who did not improve within 72 hours were offered a re-inoculation. 14 individuals improved within 72 hours of the first dose and remained asymptomatic for 8 weeks. The 6 initial non-responders underwent retreatment and 5 had resolution of diarrhea after retreatment while 4 had resolution of diarrhea 8 weeks after FMT. The overall response rate in the study was 90% (95%CI 68%-98%). The only risk factor for failed initial FMT was worse pretreatment health scores (p=0.02). There were no serious adverse events in the study.
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