A combination of three probiotic strains for treatment of acute diarrhoea in hospitalised children: an open label, randomised controlled trial

Abstract

Acute diarrhoea continues to be a leading cause of morbidity, hospitalisation, and mortality worldwide, and probiotics have been proposed as a complementary therapy in the treatment of acute diarrhoea. The goal of this study is to assess the efficacy and safety of three combined probiotic strains, Bifidobacterium lactis Bi-07, Lactobacillus rhamnosus HN001, and Lactobacillus acidophilus NCFM, as an adjunct to rehydration therapy in treatment of acute watery diarrhoea in hospitalised children. Eligible diarrheal children were randomised into intervention group (IG, n=96, conventional treatment for diarrhoea in combination with probiotics) and control group (CG, n=98, conventional treatment for diarrhoea without probiotics). The primary assessments of this study were duration of diarrhoea and hospital stay and improvement in diarrhoea symptoms. Significantly more children in the IG showed improvements in diarrhoea (defined as a decrease of stool frequency to no more than four times per day and an improved stool consistency within 24-48 h after the treatment) than those in the CG (96.9 vs 79.6%, P<0.05). Children supplemented with the mixed strains had a 22.5 h shorter (121.4±13.7 h vs 143.9±19.8 h) mean duration of diarrhoea and 1.2 d shorter hospital stays (5.1±1.2 d vs 6.3±1.4 d) than children only receiving the rehydration therapy (P<0.05). The prevalence of constipation of children in the IG (3.1%) was markedly lower (P<0.05) than that of children in the CG (13.3%) after treatment. In conclusion, the mixture of three probiotic strains given to children aged 1-3 years resulted in shorter durations of diarrhoea and hospitalisation and a higher percentage of improved children.

Systematic review with meta‐analysis: Probiotics for treating acute diarrhoea in children with dehydration

“…Data regarding therapy‐related adverse events were collected in 14 studies 8–13,15,19–24 . No adverse effects were observed in the experimental and control groups.…”

“…Included trials were carried out in countries such as India (three RCTs), [8][9][10] Turkey (four RCTs), [11][12][13][14] Thailand (two RCTs), 15,16 Pakistan (two RCTs), 17,18 Italy (one RCT), 19 Australia (one RCT), 20 Bolivia (one RCT), 21 Peru (one RCT) 22 and China (two RCTs). 23,24 Fourteen studies tested a single organism and three studies tested combinations of between two to three organisms. Meanwhile, the doses of probiotics ranged from10 8 CFU/d-10 12 CFU/d.…”

“…Subgroup analysis based on location showed a reduction in duration of diarrhoea in studies performed in West Asia (four RCTs, [11][12][13][14] n = 542, mean difference − 33.30 h, CI −38.22 to −26.39, no heterogeneity), East Asia (four RCTs, 15,16,23,24 n = 452, mean difference −22.44 h, CI −26.61 to −18.26, no heterogeneity), Europe (one RCT, 19 n = 69, mean difference −28.80 h, CI −50.47 to −7.13) and South America (one RCT, 21 n = 50, mean difference −17.50 h, CI −31.92 to −3.08), but not in South Asia (two RCTs, 9,10 n = 794, mean difference 0.78 h, CI −6.34 to 7.90, low heterogeneity, I 2 = 45).…”

“…Das 2016 8 evaluated Saccharomyces boulardii in children admitted with acute watery diarrhoea and moderate to severe dehydration in India. The median duration of Subgroup analysis based on type of probiotics showed a reduction in duration of diarrhoea with S. boulardii (three RCTs, 11,12,14 n = 390, mean difference −27.93 h, CI −35.60 to −20.27, low heterogeneity, I 2 = 38%), L. reuteri (two RCTs, 13,19 n = 196, mean difference −32.41 h, CI −41.40 to −23.71, no heterogeneity, I 2 = 0), Bifidobacterium lactis (one RCT, 14 n = 50, mean difference − 69.60 h, CI −88.99 to −50.21) and two or more probiotics (three RCTs, 21,23,24 n = 403, mean difference − 22.57, CI −26.78 to −18.36, no heterogeneity), but not with Lactobacillus GG (two RCTs, 10,15 n = 672, mean difference 2.48 h, CI −5.42 to 10.38, high heterogeneity, I 2 = 81%), Lactobacillus sporogenes (one RCT, 9 n = 148, mean difference −2.50 h, CI −9.25 to 4.25) and Lactobacillus acidophilus (one RCT, 16 n = 73, mean difference −13.60 h, CI −28.10 to 0.90).…”

“…Subgroup analysis based on patient source showed a reduction in duration of diarrhoea among hospital patients (11 RCTs, [9][10][11][12][13]15,16,19,21,23,24 n = 1831, mean difference − 17.58 h, CI −20.38 to −14.78, high heterogeneity, I 2 = 87%), emergency patients (two RCTs, 12,14 n = 126, mean difference −23.83 h, CI −34.17 to −13.49, high heterogeneity, I 2 = 70%) and outpatients (one RCT, 12 n = 92, mean difference −29.10 h, CI −36.19 to −22.01).…”