Randomized, Placebo-Controlled, Double-Blind and Open-Label Studies in the Treatment and Prevention of Acute Diarrhea With Enterococcus faecium SF68.

Autor:	Greuter T; Division of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.; Center for Gastroenterology, Zurich, Switzerland., Michel MC; Department of Pharmacology, Johannes Gutenberg University, Mainz, Germany., Thomann D; Sanofi-Aventis Schweiz GmbH, Vernier, Switzerland., Weigmann H; Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany., Vavricka SR; Division of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.; Department of Internal Medicine, GZO Zurich Regional Health Center, Wetzikon, Switzerland.
Jazyk:	angličtina
Zdroj:	Frontiers in medicine [Front Med (Lausanne)] 2020 Jun 19; Vol. 7, pp. 276. Date of Electronic Publication: 2020 Jun 19 (Print Publication: 2020).
DOI:	10.3389/fmed.2020.00276
Abstrakt:	Enterococcus faecium SF68® (SF68) is a licensed pharmaceutical for treatment and prevention of diarrhea in Austria, Italy and Switzerland. However, as for other probiotics, evidence for its efficacy is based on small to medium-sized studies. Four unpublished studies on the treatment of acute diarrhea and the prevention of antibiotic-associated diarrhea were analyzed: one randomized, double blind, placebo-controlled trial (RCT) for treatment ( n = 1,143), one open-label study for treatment ( n = 5,093), one RCT for prevention ( n = 1,397) and one open-label study for prevention ( n = 4,340). Patients in the treatment-arm and the open-label studies received SF68 (b.i.d. for the prevention studies, t.i.d. for the treatment trials) for 7 days. Primary end points were time to resolution of diarrhea (treatment) and percentage of development of diarrhea (prevention). The primary endpoint of the treatment study was met with a decreased time to resolution of diarrhea in SF68-treated patients compared to controls (median 3 vs. 4 days, p < 0.001). Time to resolution of secondary symptoms was also significantly reduced. Preventive treatment with SF68 was more effective than placebo with development of diarrhea in 8.6 vs. 16.2% ( p < 0.001). Results from the open-label studies were consistent with the RCTs. The incidence of adverse events were low (1.1 and 1.4% in the RCT and 4.7 and 7.4% in the open-label studies). SF68 is effective and safe in the treatment of acute diarrhea and prevention of antibiotic-associated diarrhea. (Copyright © 2020 Greuter, Michel, Thomann, Weigmann and Vavricka.)
Databáze:	MEDLINE
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