AUTHOR=Chen Ke , Zeng Kaihong , Jin Shanshan , Ma Yu , Cai Limei , Xu Ping , Nie Yang , Luo Li , Yu Qinghua , Liu Changqi 

TITLE=Lacticaseibacillus rhamnosus LRa05 in the treatment of acute diarrhea in children: a randomized controlled trial

JOURNAL=Frontiers in Nutrition

VOLUME=11

YEAR=2024

URL=https://www.frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1479186

DOI=10.3389/fnut.2024.1479186

ISSN=2296-861X

ABSTRACT=<sec><title>Introduction</title><p>The goal of this study is to assess the efficacy and safety of <italic>Lacticaseibacillus rhamnosus</italic> LRa05, as an adjunct to the treatment of acute watery diarrhea in children.</p></sec><sec><title>Methods</title><p>Eligible diarrheal children were randomized into intervention group (IG, <italic>n</italic> = 57) and control group (CG, <italic>n</italic> = 54), and given probiotics or placebo, respectively.</p></sec><sec><title>Results</title><p>The total duration of diarrhea in the IG (121.4 ± 13.7 h) was significantly shorter than that in the CG (143.9 ± 19.8 h, <italic>p</italic> &lt; 0.001). More children in the IG showed improvements in diarrhea than those in the CG for both per protocol analysis (70.2 vs. 46.3%, <italic>p</italic> = 0.01) and intention-to-treat analysis (66.7 vs. 41.7%, <italic>p</italic> = 0.003). The LL-37 levels in the IG was markedly higher than that in the CG after the intervention (4349.35 ± 1143.86 pg./g vs. 3682.49 ± 869.21 pg./g, <italic>p</italic> = 0.039). The intervention led to higher abundance of <italic>Bifidobacterium longum</italic> and lower abundance of <italic>Enterococcus faecium</italic>, <italic>Lactobacillus rhamnosus</italic>, and <italic>Bacteroides fragilis</italic> (<italic>p</italic> &lt; 0.05). LRa05 treatment upregulated the functional genes of gut microbiota involving immunity regulation.</p></sec><sec><title>Discussion</title><p>Administration of the <italic>Lacticaseibacillus rhamnosus</italic> LRa05 at a dose of 5 × 10<sup>9</sup> CFU/day to children aged 0-3 years resulted in shorter duration of diarrhea, faster improvement in fecal consistency, and beneficial changes in gut microbiome composition and gene functions.</p></sec><sec id="sec5001"><title>Clinical trial registration</title><p>The present study has been approved and registered in the Chinese Clinical Trial Registration Center with the registration number of ChiCTR2100053700 (<uri xlink:href="https://www.chictr.org.cn/showproj.html?proj=141082" xmlns:xlink="http://www.w3.org/1999/xlink">https://www.chictr.org.cn/showproj.html?proj=141082</uri>).</p></sec>