Comparison between combined clostridium butyricum and bifidobacterium living powders and saccha-romyces boulardii for prevention of antibiotic-associated diarrhea in children:a randomized,controlled clinical trial / 中国小儿急救医学

ABSTRACT

Objective To evaluate the protection of combined clostridium butyricum and bifidobac-terium living powders for antibiotic-associated diarrhea ( AAD ) with all kinds of infections in hospitalized children,and to compare the therapeutic effect with saccharomyces boulardii. Methods This study was a prospective,randomized case-control clinical trial which collected the data of the hospitalized children with all kinds of infections in Pediactric Department of Shengjing Hospital of China Medical University between May 2011 to May 2012. A total of 552 cases were enrolled and 480 cases completed the study. A total of 240 chil-dren were in experimental group,80 cases received combined clostridium butyricum and bifidobacterium liv-ing powders 840 mg per time,twice a day and the other 160 cases received saccharomyces boulardii 250 mg per time,twice a day,for one week; the control group took none of probiltics. Two groups received routine antibiotic therapy. Everyday′s defecate frequency was recorded, the traits of excrement according to bristol stool assessment scale were evaluated,the incidence of diarrhea and drug related adverse reactions were coun-ted. Results During the studied 7 days,the AAD incidence was 4. 2%(10/240) in experimental group and 20. 4%(49/240) in control group,there was significant difference between two groups. The risk of AAD in experimental group decreased 58. 5%. Compared to saccharomyces boulardii,combined clostridium butyricum and bifidobacterium living powders decreased 38. 2% (RR=0. 728, 95%CI 0. 257~0. 784, P=0. 009). Compared to control group,the average defecate frequency decreased in experimental group,diarrhea duration contracted,there was statistic difference between two groups ( P<0. 01 ) . No drug related adverse reactions happened during the trial. Conclusion Both combined clostridium butyricum and bifidobacterium living powders and saccharomyces boulardii could effectively reduce the risk of AAD in hospitalized children with bacterial infection,relieve diarrhea symptoms,short the duration of diarrhea,and did not find the adverse reac-tions. Combined clostridium butyricum and bifidobacterium living powders and saccharomyces boulardii had the same protective effect for AAD of northern China children.