Effect of Lactobacillus rhamnosus LGG and Bifidobacterium animalis subspecies lactis BB-12 combination on the duration of diarrhea and length of hospital stay in children with acute diarrhea in Turkey

Abstract

Background Acute diarrhea continues to be a leading cause of morbidity and mortality worldwide. The main therapy for all individuals with dehydration caused by diarrhea is oral rehydration. Probiotics have been proposed as a complementary therapy in the treatment of acute diarrhea. We aim to evaluate the effect of a combination of Lactobacillus rhamnosus GG (LGG) with Bifidobacterium animalis subspecies lactis BB-12 (BB-12) on the duration of diarrhea and length of hospital stay in children with acute diarrhea.Methods A multicenter, randomized (240 children, 2:1 randomized for probiotic vs. control), single blind, hospital based clinical trial was performed in children (6 to 60 months) with acute watery diarrhea lasting more than 24 but less than 72 hours, requiring hospitalization. We enrolled children with clinical signs of mild to moderate dehydration. The children received conventional therapy with or without the combination of LGG and BB-12 (1 × 109 colony forming units for each) for 5 days. The primary endpoint was the duration of diarrhea (in hours), defined as the first normal stool according to the Bristol stool score (score < 5). Secondary outcome measures were duration of hospitalization (days) and percentage of children without diarrhea at 72 hours of intervention.Results In total, data from 218 of 240 children could be evaluated (150 in the probiotic group and 68 in the control group). The duration of diarrhea was significantly reduced in the LGG and BB-12 group compared to the control group (74.5 ± 40.8 hours vs. 98.4 ± 22.9 hours, P<0.001). The percentage of diarrhea-free children was significantly larger in the LGG and BB-12 group at 72 hours compared to the control (60% vs. 33.8%, P<0.001). Mean length of hospital stay was similar for both groups (5.03 ± 2.3 days vs. 5.25 ± 1.3 days, P>0.05).Conclusion This is the first clinical trial to test the combination of LGG and BB-12, and show its effects on diarrhea duration in children with acute infectious diarrhea. The duration of diarrhea was reduced by approximately 24 hours in the hospitalized children. Further randomized controlled clinical trials including outpatient cases with acute infectious diarrhea in addition to hospitalized cases should be conducted to assess the potential effects of the combination in more detail.