کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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5719443 | 1607412 | 2017 | 5 صفحه PDF | دانلود رایگان |
ObjectivesTo determine if Lactobacillus plantarum DSM9843 (LP299V) reduces the frequency of antibiotic-associated loose/watery stools and gastrointestinal symptoms, and can be administered safely to children who are prescribed antibiotics.Study designWe performed a prospective, double-blind, randomized, placebo-controlled, multicenter, parallel-group study in children receiving outpatient antibiotic therapy in primary healthcare settings. The children were given LP299V/placebo during the antibiotic therapy and for 1 week after the end of treatment. The primary outcome measure was the incidence of at least 1 loose/watery stool (type 6 or 7 according to the Bristol Stool Form Scale). Gastrointestinal symptoms (abdominal pain, abdominal distention, vomiting, and flatulence) were followed up until 1 week after the last intake of the study product.ResultsA total of 438 children (male: 235, female: 203) aged 1-11 years (meanâ±âSD: 5.2â±â2.7) were randomized to receive LP299V (Nâ=â218) or placebo (Nâ=â220). The incidence of loose/watery stools in the 2 study groups (LP299V and placebo) was similar, 39% vs 44.5% respectively (Pâ=â.26) as was the mean number of loose/watery stools (3.9â±â3.5 vs 4.7â±â6.3; Pâ=â.9). Antibiotic-associated diarrhea (defined as â¥3 loose/watery stools/24 hours starting from 2 hours after initiation of antibiotic treatment until the end of the study) occurred in 2.8% of the subjects receiving LP299V compared with 4.1% in the placebo arm (Pâ=â.4). The number of children with abdominal symptoms did not differ between the groups.ConclusionsNo beneficial effect of LP299V compared with placebo was observed for the incidence of loose/watery stools, mean number of loose/watery stools, or the incidence of abdominal symptoms. LP299V had a satisfactory safety profile.Trial registrationClinicalTrials.gov: NCT01940913.
Journal: The Journal of Pediatrics - Volume 186, July 2017, Pages 82-86