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

Ke Chen; Shanshan Jin; Yu Ma; Limei Cai; Ping Xu; Yang Nie; Li Luo; Qinghua Yu; Yang Shen; Weiwei Ma; Zengyuan Zhou; Changqi Liu

doi:10.1016/j.nut.2023.112052

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

Nutrition. 2023 Jul:111:112052. doi: 10.1016/j.nut.2023.112052. Epub 2023 Mar 31.

Authors

Ke Chen¹, Shanshan Jin², Yu Ma³, Limei Cai⁴, Ping Xu⁵, Yang Nie⁶, Li Luo⁷, Qinghua Yu⁸, Yang Shen⁸, Weiwei Ma⁹, Zengyuan Zhou², Changqi Liu¹⁰

Affiliations

¹ Department of Nutrition, Chengdu Women's & Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu City, Sichuan Province, P.R., China. Electronic address: kechen@uestc.edu.cn.
² Department of Nutrition, Chengdu Women's & Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu City, Sichuan Province, P.R., China.
³ Department of Neonatology, Dayi Maternal and Child Health Care Hospital, Dayi County City, Sichuan Province, P.R., China.
⁴ Department of Neonatology, Qingbaijiang Maternal and Child Health Care Hospital, Chengdu City, Sichuan Province, P.R., China.
⁵ Department of Child Health Care, Qingbaijiang Maternal and Child Health Care Hospital, Chengdu City, Sichuan Province, P.R., China.
⁶ Department of Child Health Care, Chongzhou Maternal and Child Health Care Hospital, Chongzhou City, Sichuan Province, P.R., China.
⁷ Department of Pediatrics, Dayi Maternal and Child Health Care Hospital, Dayi County, Sichuan Province, P.R., China.
⁸ Laboratory of Microbiology, Immunology and Metabolism, Diprobio (Shanghai) Co., Limited, Shanghai City, P.R., China.
⁹ College of Pharmacy, Heilongjiang University of Chinese Medicine, Harbin City, Heilongjiang Province, P.R., China.
¹⁰ School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.

PMID: 37172455
DOI: 10.1016/j.nut.2023.112052

Abstract

Objective: 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.

Method: 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.

Result: 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.

Conclusions: 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.

Keywords: Children; Diarrhea; Gut microbiota; Probiotic.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Bifidobacterium
Child
Diarrhea* / drug therapy
Double-Blind Method
Feces / microbiology
Humans
Probiotics* / therapeutic use