BACKGROUND: The therapeutic value of Bioflorin, a preparation containing Enterococcus SF 68 strain, was evaluated in adult patients with acute diarrhea. METHODS: In a double-blind randomized trial we compared the effect of SF 68 strain in a dose of 150 x 10(6) colony-forming units three times a day for 5 days compared with placebo on the duration of diarrhea in 211 adults. RESULTS: Patients receiving SF 68 had a reduced duration of diarrhea compared with placebo, with a highly statistically significant difference between treatments. The proportion of patients with continuing diarrhea during the 2nd day of treatment was 61% in patients receiving SF 68 and 96% in those receiving placebo (P < 0.01). During the 3rd day diarrhea was still present in 8% of patients given SF 68, compared with 66% of those given placebo (P < 0.01). The mean (+/-SD) duration of diarrhea was 1.69 days (0.6) in patients given SF 68 compared with 2.81 days (0.9) in those given placebo. When pathogens were found in the first stool culture, they could not be detected at post-treatment examination. No adverse reactions were observed. CONCLUSIONS: Oral bacteriotherapy with SF 68 strain shortens the duration and the severity of diarrhea in adults and represents a safe and effective approach to re-establishing a balanced microbial flora in this condition.
RCT Entities:
BACKGROUND: The therapeutic value of Bioflorin, a preparation containing Enterococcus SF 68 strain, was evaluated in adult patients with acute diarrhea. METHODS: In a double-blind randomized trial we compared the effect of SF 68 strain in a dose of 150 x 10(6) colony-forming units three times a day for 5 days compared with placebo on the duration of diarrhea in 211 adults. RESULTS:Patients receiving SF 68 had a reduced duration of diarrhea compared with placebo, with a highly statistically significant difference between treatments. The proportion of patients with continuing diarrhea during the 2nd day of treatment was 61% in patients receiving SF 68 and 96% in those receiving placebo (P < 0.01). During the 3rd day diarrhea was still present in 8% of patients given SF 68, compared with 66% of those given placebo (P < 0.01). The mean (+/-SD) duration of diarrhea was 1.69 days (0.6) in patients given SF 68 compared with 2.81 days (0.9) in those given placebo. When pathogens were found in the first stool culture, they could not be detected at post-treatment examination. No adverse reactions were observed. CONCLUSIONS: Oral bacteriotherapy with SF 68 strain shortens the duration and the severity of diarrhea in adults and represents a safe and effective approach to re-establishing a balanced microbial flora in this condition.
Authors: Ulrike Lodemann; Salah Amasheh; Judith Radloff; Martina Kern; Astrid Bethe; Lothar H Wieler; Robert Pieper; Jürgen Zentek; Jörg R Aschenbach Journal: Dig Dis Sci Date: 2016-12-19 Impact factor: 3.199