García Trallero O, Herrera Serrano L, Bibián Inglés M, Roche Vallés D, Rodríguez A M
Luis Herrera Serrano, Schwabe Farma Ibérica, Avenida de la Industria, 4, Edificio 2, escalera 1, 2º, 28108 Alcobendas (Madrid) Spain.
Rev Esp Quimioter. 2019 Jun;32(3):268-272. Epub 2019 Mar 26.
The aim of this study is to analyze the effect, safety and tolerability of a specific probiotic combination of Lactobacillus and Bifidobacterium strains (Pearls IC©) on antibiotic associated diarrhea due to amoxicillin-clavulanic acid treatment.
Pilot, unicentric, randomized, double-blind, parallel group, placebo-controlled study (probiotic vs. placebo for 30 days). Target population: Adult patients, both sexes treated with amoxicillin-clavulanic acid (850mg / 125mg every 8h /orally) for 7 days who attended the Emergency Department (Dexeus Hospital, Barcelona) between January and April of 2018 with prior signed informed consent with a follow up at 30 days. Variables: The differences between day 0 and day 30 of the number of daily stools and duration of diarrhea were evaluated; Stool consistency according to Bristol Stool Form, Quality of intestinal life. Subjective evaluation and evaluation of adverse effects of the product through a specifically designed questionnaire.
Thirty-six subjects were included (18 per group) 25 females and 11 males, average age of 38.5 years (range 19-65 years). Pearls IC© delayed between 4 and 5 days the appearance of the diarrheic episode vs. placebo (p <0.001). The results of the quality of life assessment showed an improvement at the end of the 30 days period but without difference vs placebo. The results of the subjective assessment were in favor of the probiotic with higher rate of like responses than placebo.
Pearls IC© demonstrated its beneficial effect on antibiotic associated diarrhea by delaying the onset of diarrhea and showed a tendency to decrease the number of daily stools vs. placebo.
本研究旨在分析特定的乳酸杆菌和双歧杆菌菌株组合（Pearls IC©）对阿莫西林-克拉维酸治疗所致抗生素相关性腹泻的疗效、安全性和耐受性。
先导性、单中心、随机、双盲、平行组、安慰剂对照研究（益生菌与安慰剂治疗30天）。目标人群：2018年1月至4月期间在急诊科（巴塞罗那德克塞斯医院）接受阿莫西林-克拉维酸（850mg/125mg，每8小时口服一次）治疗7天的成年患者，男女不限，事先签署知情同意书，并在30天进行随访。变量：评估第0天和第30天每日排便次数和腹泻持续时间的差异；根据布里斯托大便形态评估大便稠度、肠道生活质量。通过专门设计的问卷对产品进行主观评价和不良反应评价。
共纳入36名受试者（每组18名），其中女性25名，男性11名，平均年龄38.5岁（范围19 - 65岁）。与安慰剂相比，Pearls IC©使腹泻发作延迟4至5天（p<0.001）。生活质量评估结果显示，在30天期末有所改善，但与安慰剂相比无差异。主观评估结果支持益生菌，喜欢该产品的反应率高于安慰剂。
Pearls IC©通过延迟腹泻发作，显示出其对抗生素相关性腹泻的有益作用，并且与安慰剂相比，有减少每日排便次数的趋势。
