RESUMO
OBJECTIVES: To 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 DESIGN: We 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. RESULTS: A total of 438 children (male: 235, female: 203) aged 1-11 years (mean ± SD: 5.2 ± 2.7) were randomized to receive LP299V (N = 218) or placebo (N = 220). The incidence of loose/watery stools in the 2 study groups (LP299V and placebo) was similar, 39% vs 44.5% respectively (P = .26) as was the mean number of loose/watery stools (3.9 ± 3.5 vs 4.7 ± 6.3; P = .9). Antibiotic-associated diarrhea (defined as ≥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 (P = .4). The number of children with abdominal symptoms did not differ between the groups. CONCLUSIONS: No 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 REGISTRATION: ClinicalTrials.gov: NCT01940913.