A new study with LactoSpore® in Acute diarrhea in children
The present randomized, double-blind, placebo-controlled trial showed that LactoSpore® supplemented with ORS and Zn had comparatively more efficacy than ORS and Zn treatment alone in managing acute diarrhea in 110 children without malnutrition, aged from 3 to 8 years.
Acute diarrhea in children is generally managed by replacing the lost fluid with oral rehydration solution (ORS). Probiotic supplementation has been reported to reduce the severity of diarrhea. In the present study, Sabinsa investigated the effect of Weizmannia coagulans (Bacillus coagulans) MTCC 5856 (LactoSpore®), along with ORS on acute diarrhea of all causes in nonhospitalized children.
A total of 110 children of ages between 1 and 10 were enrolled in a double-blind placebo-controlled study and were randomly allocated to receive W. coagulans MTCC 5856 (4 × 108 spores, N = 54) + ORS and zinc (Zn) or a placebo (N = 56) + ORS and (Zn) for 5 days. The consistency of the stool, mean duration of diarrhea in hours, mean diarrhea frequency per day, and the dehydration status were collected as efficacy endpoints. Safety was evaluated by the occurrence of adverse events.
The mean age of the children was 5.55 ± 2.57 years (61 boys and 49 girls). The mean duration of diarrhea was 51.31 ± 20.99 h in the W. coagulans MTCC 5856 group and 62.74 ± 24.51 h in the placebo (p = 0.011) group. The frequency of diarrhea was lower in children supplemented with the probiotic, but the difference was not statistically significant. The perceived efficacy score and dehydration status improved significantly in the W. coagulans MTCC 5856 group compared with the placebo group. No adverse events were recorded.
The results of the study suggest that W. coagulans MTCC 5856 could be supplemented along with ORS and zinc to reduce the duration of diarrhea in non-hospitalized children.
The present randomized, double-blind, placebo-controlled trial showed that W. coagulans MTCC 5856 supplemented with ORS and Zn had comparatively more efficacy than ORS and Zn treatment alone in managing acute diarrhea in children without malnutrition. Further, this is the first time the specific strain of W. coagulans MTCC 5856 is being tested for the safety and efficacy in children with acute diarrhea, which make the results clinically important for health professionals, including general practitioners, general pediatricians, pediatric gastroenterologists, and nutritionists.
Probiotic Weizmannia coagulans MTCC 5856 as adjunct therapy in children’s acute diarrhea—a randomized, double-blind, placebo-controlled study, Muhammed Majeed and al., doi: 10.3389/fped.2023.1338126, Frontiers in Pediatrics, PUBLISHED 10 January 2024