AUTHOR=Cruchet Silvia , Hirsch Sandra , Villa-López Diana , Moreno-Portillo Mucio , Palomo Juan C. , Abreu-Abreu Ana T. , Abdo-Francis Juan M. , Jiménez-Gutiérrez Carlos , Rojano Martin , López-Velázquez Gabriel , Gutiérrez-Castrellón Pedro 

TITLE=Limosilactobacillus reuteri DSM 17938 and ATCC PTA 6475 for the treatment of moderate to severe irritable bowel syndrome in adults: a randomized controlled trial

JOURNAL=Frontiers in Gastroenterology

VOLUME=2

YEAR=2024

URL=https://www.frontiersin.org/journals/gastroenterology/articles/10.3389/fgstr.2023.1296048

DOI=10.3389/fgstr.2023.1296048

ISSN=2813-1169

ABSTRACT=<sec><title>Background</title><p>Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder in adults. Systematic reviews with meta-analyses have demonstrated the efficacy and safety of probiotics in improving symptoms of IBS.</p></sec><sec><title>Aim</title><p>The aim of the study was to demonstrate the efficacy and safety of <italic>Limosilactobacillus reuteri</italic> (<italic>L. reuteri</italic>) DSM 17938 combined with <italic>L. reuteri</italic> ATCC PTA 6475 regarding improving the symptoms associated with IBS in adults.</p></sec><sec><title>Methods</title><p>A randomized, double-blind, placebo-controlled clinical trial was conducted in 140 adults aged 18 years to 65 years with a diagnosis of IBS (based on the Rome IV criteria). After 2 weeks of washout, subjects were randomized to receive either 2 × 10<sup>8</sup> colony-forming units (CFUs) of <italic>L. reuteri</italic> DSM 17938 combined with <italic>L. reuteri</italic> ATCC PTA 6475 plus standard of care or placebo plus standard of care for 14 weeks, followed by a post-intervention period of 2 additional weeks. Changes in gastrointestinal symptoms (as measured with the GSRS-IBS), stool pattern (as measured with the Bristol scale), quality of life, depression and anxiety, frequency of adverse events, and fecal calprotectin concentrations were evaluated.</p></sec><sec><title>Results</title><p>In total, 70 subjects were allocated to receive <italic>L. reuteri</italic> and 70 were allocated to receive placebo. During the pre-randomization phase, no differences were observed between the groups in terms of IBS-associated symptoms and stool consistency. Starting at week 6 of the intervention, subjects in group <italic>L. reuteri</italic> showed a significant improvement in IBS-associated symptoms (<italic>p</italic> &lt; 0.01). A significant improvement was also observed in fecal calprotectin concentration in the <italic>L. reuteri</italic> group at the end of interventions (30.2 ± 11.8 mg/g of stool in the <italic>L. reuteri</italic> group and 41.6 mg/g ± 10.7 mg/g in the placebo group; <italic>p</italic> = 0.019). The frequency of adverse events was similar between groups.</p></sec><sec><title>Conclusions</title><p>A twice-a-day intervention for 14 weeks is safe and effective, reduces the symptoms associated with IBS in adults aged 18 years to 65 years, improves stool consistency, and reduces symptoms associated with anxiety after 6 weeks.</p></sec>