Abstract

This randomized, double-blind, placebo-controlled, multi-center study investigated the clinical efficacy of two probiotic strains on abdominal pain severity and symptomology in irritable bowel syndrome (IBS). Three hundred and thirty adults, aged 18 to 70 years, with IBS according to Rome IV criteria were allocated (1:1:1) to receive placebo, Lactobacillus acidophilus DDS-1 (1 × 1010 CFU/day) or Bifidobacterium animalis subsp. lactis UABla-12 (1 × 1010 CFU/day) over six weeks. The primary outcome was the change in Abdominal Pain Severity - Numeric Rating Scale (APS-NRS). Over the intervention period, APS-NRS was significantly improved in both probiotic groups vs. placebo in absolute terms (DDS-1: −2.59 ± 2.07, p = 0.001; UABla-12: −1.56 ± 1.83, p = 0.001) and in percentage of significant responders (DDS-1: 52.3%, p < 0.001); UABla-12 (28.2%, p = 0.031). Significant amelioration vs. placebo was observed in IBS Symptom Severity Scale (IBS-SSS) scores for L. acidophilus DDS-1 (−133.4 ± 95.19, p < 0.001) and B. lactis UABla-12 (−104.5 ± 96.08, p < 0.001) groups, including sub-scores related to abdominal pain, abdominal distension, bowel habits and quality of life. Additionally, a significant normalization was observed in stool consistency in both probiotic groups over time and as compared to placebo. In conclusion, L. acidophilus DDS-1 and B. lactis UABla-12 improved abdominal pain and symptom severity scores with a corresponding normalization of bowel habits in adults with IBS.

Highlights

  • Irritable bowel syndrome (IBS), a functional disorder of the gastrointestinal tract, is characterized by chronic or recurrent abdominal pain and altered bowel habits [1]

  • Significant amelioration vs. placebo was observed in IBS Symptom Severity Scale (IBS-SSS) scores for L. acidophilus DDS-1 (−133.4 ± 95.19, p < 0.001) and B. lactis UABla-12 (−104.5 ± 96.08, p < 0.001)

  • The current study focused on abdominal pain as the primary outcome as it is a defining characteristic of IBS and a driver of healthcare resource utilization [20]

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Summary

Introduction

Irritable bowel syndrome (IBS), a functional disorder of the gastrointestinal tract, is characterized by chronic or recurrent abdominal pain and altered bowel habits [1]. Diagnosis of IBS is based on Rome IV criteria, a symptom-based classification system [4]. Current estimates report a worldwide prevalence of approximately 12%, making IBS the most common functional gastrointestinal disorder [4]. Clinical management is challenging due to the heterogeneity of symptoms, and no validated treatment algorithm exists [5]. Systematic reviews have demonstrated a limited but significant effect of probiotics over placebo on IBS symptoms [6,7,8,9]. Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer a health benefit to the host [10].

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