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One patient died on the eleventh day of follow-up due to an acute myocardial infarction not related to the study intervention, and that patient had an excellent clinical response during the short follow-up with no adverse events after the intervention. There were no differences in baseline characteristics between the groups and in the clinical response rate.Īdverse events were recorded in 42.3% of patients and were predominantly burping (14.8%), constipation (19%), and vomiting (9%). Patients with a first R-CDI accounted for 76.2% of the totality of enrolled patients. Overall, both groups of patients had a reduction in bowel movements per day from 8.6 to 3.2 (62.7% reduction, p=0.001) in the first 48 h and the Bristol score was also reduced from 6.5 to 5.4 in the same period, but did not reach statistical significance ( p=0.15). The bold value indicates that it is statistically significant because it is lower than 0.05. The study was ended when the minimum number of patients for each arm was completed. Feces from each patient were collected before transplant on day 0 (sample A) and posttransplant on days 3 (sample B), 7 (sample C), and 28 (sample D).įollow-up of patients was carried out from inclusion in the study up to 90 days. Clinical data regarding bowel movements, fever, and abdominal pain as well as laboratory parameters were registered. The randomized patients received treatment according to the intervention they were allocated. A patient identification (ID) was assigned to each participant, and samples collected were identified with this ID. Patients stopped any antibiotic at least 24 h before FMT.Įach patient received 15 frozen capsules PO every 12 h for a total of 4 doses (a total of 60 capsules). Once the patients had signed the informed written consent, they were randomized by the research coordinator in a 1 : 1 ratio to receive either FMT or FMT-L. In this pilot study, we proposed a sample size of 10 patients in each group.
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FMT with the addition of Lactobacillus spp. We conducted a comparative study to explore the differences in therapeutic efficacy and intestinal microbiome of FMT vs. to FMT might enhance the efficacy of the latter by enhancing engraftment and therefore provides clinical advantages. This effect is mainly attributable to their acidophilic effect and lowering of pH in the intestinal microenvironment. have shown to serve as a preventive measure for the development of CDI in high-risk patients and in those who are recipients of antibiotic therapy. It has been used for the treatment of patients with R-CDI with an efficacy of 87–91%, and has shown to be a more effective treatment than vancomycin.
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Recurrence occurs in up to 20–30% of patients, and subsequent treatments are less and less efficacious.įecal microbiota transplant (FMT) has been used in patients with recurrent events of CDI (R-CDI) with great success, and it is now a part of the IDSA guidelines for patients with multiple recurrences. The spectrum of CDI is extensive, starting from asymptomatic carriage to severe diarrhea that may progress to pseudomembranous colitis and toxic megacolon.
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Clostridioides ( Clostridium) difficile infection (CDI) is a complicated and recurrent communicable disease with limited proven treatment options.