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Abstract

Background: Previous studies have shown that selected strains of lactobacilli that are administered orally result in a modest reduction of diarrhea duration. However, duration alone is not considered optimal for therapeutic evaluation of any agent in diarrhea.

Objective: To examine the effect of a new probiotic, Lactobacillus paracasei strain ST11 (ST11), in acute childhood diarrhea by using evaluation criteria recommended by the World Health Organization.

Methods: In a randomized, double-blind, placebo-controlled clinical trial, 230 male infants and young children, 4 to 24 months of age, presenting with diarrhea of <2 days' duration were admitted to the metabolic research ward of the International Centre for Diarrheal Disease Research, Bangladesh, and fed 10(10) colony-forming units of lyophilized ST11 or placebo daily for 5 days. Stool output and frequency, oral rehydration solution intake, and excretion of rotavirus were monitored daily.

Results: No effect of ST11 treatment on severe rotavirus diarrhea was observed. However, the probiotic treatment did significantly reduce cumulative stool output (225 +/- 218 vs 381 +/- 240 mL/kg), stool frequency (27.9 +/- 17 vs 42.5 +/- 26), and oral rehydration solution intake (180 +/- 207 vs 331 +/- 236 mL/kg) in children with less-severe nonrotavirus diarrhea compared with those receiving placebo treatment. A significantly higher proportion of nonrotavirus children receiving ST11 had their diarrhea resolve within 6 days of therapy (ST11 versus placebo: 76% vs 49%).

Conclusions: ST11 has a clinically significant benefit in the management of children with nonrotavirus-induced diarrhea, but it is ineffective in those with rotavirus diarrhea.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Lactobacillus paracasei DSM 13434Reduced Oral Rehydration Solution Intake in Non-rotavirus DiarrheaBeneficial
Moderate
Lactobacillus paracasei DSM 13434Reduced Stool Output in Nonrotavirus DiarrheaBeneficial
Moderate
Lactobacillus paracasei DSM 13434Resolution of DiarrheaBeneficial
Large
Lactobacillus paracasei HA-196No Effect on Severe Rotavirus DiarrheaNeutral
Large
Lactobacillus paracasei HA-196Reduced Oral Rehydration Solution Intake in Non-rotavirus DiarrheaBeneficial
Moderate
Lactobacillus paracasei HA-196Reduced Stool FrequencyBeneficial
Moderate
Lactobacillus paracasei HA-196Reduced Stool VolumeBeneficial
Moderate
Lactobacillus paracasei HA-196Resolution of DiarrheaBeneficial
Large
Lactobacillus paracasei IMC 502No Effect on Severe Rotavirus DiarrheaNeutral
Large
Lactobacillus paracasei UALpc-04Improved Management of DiarrheaBeneficial
Large
Lactobacillus paracasei UALpc-04Improved Management of Rotavirus-Induced DiarrheaNeutral
Small
Lactobacillus paracasei VPro 224No Change in Rotavirus DiarrheaNeutral
Large
Lactobacillus paracasei VPro 224Reduced Oral Rehydration Solution Intake in Non-rotavirus DiarrheaBeneficial
Moderate
Lactobacillus paracasei VPro 224Reduced Stool Output in Nonrotavirus DiarrheaBeneficial
Moderate
Lactobacillus paracasei VPro 224Resolution of DiarrheaBeneficial
Large
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