Adjunctive efficacy of Lactis XLTG11 for Acute diarrhea in children: A randomized, blinded, placebo-controlled study

The aim of this study was to assess the efficacy and safety of Bifidobacterium animalis sp. Lactis XLTG11, as an adjunctive treatment for acute watery diarrhea in children, using a randomized, double-blinded, placebo-controlled study design.

Eligible children with diarrhea were randomly assigned into one of two groups: an intervention group (IG, n = 35), which received conventional treatment plus the probiotic, and a control group (CG, n = 35), which received only conventional treatment. Fecal samples were collected from all children before and after the intervention to measure biochemical indices and analyze gut microbiome (GM) composition.

The duration of diarrhea (121.3 ± 11.5 h) and hospital length of stay (3.4 ± 1.1 d) in the IG were significantly shorter than those in the CG (133.4 ± 14.1 h and 4 ± 1.3 d, respectively; P < 0.001 and P = 0.041, respectively). A higher percentage of children in the IG showed improvements compared with the CG (57.1% versus 25.7%, P < 0.001). The calprotectin level in the IG was significantly lower than that in the CG after the intervention (928.91 ± 158.90 ng/g versus 1029.86 ± 133.25 ng/g, P = 0.028). XLTG11 administration led to a higher abundance of species B. longum and < breve, increased α-diversity of the GM (P < 0.05), and upregulated the functional genes of the GM related to immunity and nutrient absorption.

Administration of XLTG11 at a dose of 1 × 10¹⁰ CFU/d was effective in reducing the duration of diarrhea, inducing beneficial changes in GM composition and gene functions.