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▎WuXi AppTec content team editor
Clostridium difficile can cause colon infections and is one of the most common causes of
nosocomial infections and death.
Treatment options for Clostridium difficile infection are limited, and oral antibiotics (including vancomycin and metronidazole) have a certain effect, but the recurrence rate is as high as 25%~30%.
Therefore, there is an urgent clinical need for a non-antibiotic approach to treat and prevent Clostridium difficile infection
.
The Lancet Gastroenterology & Hepatology has published a randomized, double-blind, placebo-controlled trial
of fecal microbiota transplantation for Clostridium difficile infection (early).
The results suggest that restoration of the microbiota through fecal microbiota transplantation is expected to be an effective treatment option
for patients with multiple relapses of Clostridium difficile.
Credit: The Lancet Gastroenterology & Hepatology
The trial was conducted at Aarhus University Hospital in Denmark.
Participants were 86 patients
over the age of 18 with first or second Clostridium difficile infection.
Patients were randomized 1:1 to fecal microbiota transplantation and placebo
.
All patients were first given oral vancomycin 125 mg four times daily for at least 10 days; Fecal microbiota transplantation and placebo were subsequently received in groups, with the first dose given on day 1 and the second dose given
between days 3 and 7.
The primary endpoint of the trial was resolution
of Clostridium difficile-associated diarrhea (CDAD) eight weeks after treatment.
All patients were tested
for salmonella, Campylobacter, Yersinia, Shigella, and enteropathogenic E.
coli using PCR.
Because the efficacy (CDAD resolution rate) of the placebo group was significantly lower than that of the fecal microbiota transplant group (p<0.
001) at the time of the interim analysis, the research team discontinued the trial
for ethical reasons.
At 8 weeks after treatment, 19 (90%) of 21 patients in the fecal microbiota transplantation group and 7 (33%) of 21 patients in the placebo group achieved resolution
of CDAD.
▲ Primary and secondary trial endpoints (Image source: Reference [1]) In terms of safety, the overall incidence of adverse events in the fecal microbiota transplantation group was 95% (20/21) and 100% (21/21)
in the placebo group.
Among them, diarrhea and abdominal pain are the most common adverse effects
.
There were three serious adverse events that could be associated with study treatment (1 in the fecal microbiome transplant group; 2 in the placebo group), but there were no deaths or colectomies
at 8 weeks follow-up.
The trial still has some limitations
.
First, premature discontinuation and low patient numbers limit extrapolated analyses
of mortality, time of onset of effect, and cost.
In addition, the results should be considered as an additive effect of fecal microbiota transplantation after vancomycin treatment, rather than evidence of the effect of fecal microbiota transplantation alone, and initial treatment with vancomycin may prevent clinical deterioration or relapse
before fecal microbiota transplantation.
Overall, in this randomized, double-blind, placebo-controlled clinical trial, fecal microbiota transplantation after vancomycin treatment was superior to vancomycin alone
in patients with first or second Clostridium difficile infection.
The effect of fecal microbiota transplantation on microbiota recovery also reflects its potential to
effectively manage the symptoms of early Clostridium difficile infection.