TREATMENT OF ACUTE INFECTIOUS DIARRHEA IN CHILDREN WITH A MIXTURE OF THREE NEW LACTOBACILLUS RHAMNOSUS STRAINS (573L/1, 573L/2, 573L/3). A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL

Abstract

Background: Multiple studies documented that Lactobacillus GG is effective in treating infectious diarrhea (ID) in children. However, the positive effect of these probiotics in ID cannot be extrapolated to other L.rhamnosus strains. A trial was conducted to evaluate the efficacy of L.rhamnosus three strain mixture (573L/1,573L/, 573L/3) with patients with ID of different causes. Methods: Children from 2 months to 5 years with acute diarrhea were enrolled into double-blind, placebo-controlled trial. They were randomly allocated either to the group receiving L.rhamnosus (at least 1,2 × 1010 CFU) twice daily for 5 days, or to the group receiving placebo. The primary outcome measure was the diarrhea duration. The secondary outcome measures were: weight gain after rehydration, diarrhea lasting longer than 7 days, presence of adverse events, and gut colonization by the applied strains. The molecular methods (PCR, PFGE) were used to demonstrate gut colonization by the applied strains. Results: 93 patients were enrolled in the study. There were no differences in admission between the groups in: age, sex, previous types of feeding, previous diarrhea duration, antibiotic usage, weight, fever prevalence, overall status and dehydration degree. Diarrhea duration in probiotic treated group was 83,6 h ± 55,6 versus 96h ± 71,5 (p = 0,36) in the control one. In children with rotavirus infection getting probiotics (n = 22/87) it was 77,5h ± 35,4 versus 115h ± 67 (p = 0,03) in the control group (n = 17/87). Presence of the used strains was detected in stools of 37/46 (80,4%) children after 5 days and 19/46 (41,3%) after 14 days, after the treatment initiation. Summary: Diarrhea duration was insignificantly shorter in a whole probiotic treated group but significantly shorter in patients with rotavirus diarrhea. No differences in secondary clinical outcomes were found among the study groups. We proved, using molecular methods, the ability of applied probiotic strains to gut colonization. Conclusion: Treatment of children with ID, with L.rhamnosus three strain mixture is safe and results in shorter duration of rotavirus diarrhea.