Efficacy and dose response of in diarrhea-predominant irritable bowel syndrome.

BACKGROUND

Probiotics have shown promise in alleviating symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D); however, the certainty of evidence is low. Well-powered randomized controlled dose-ranging trials are warranted on promising single-strain candidates.

AIM

To investigate the clinical efficacy of () Lpla33 (DSM34428) in adults with IBS-D.

METHODS

This is a randomized, double-blind, placebo-controlled, multi-center, and dose-ranging study. Three hundred and seven adults, 18-70 years of age, with IBS-D, according to Rome IV criteria, were allocated (1:1:1) to receive placebo or Lpla33 at 1 × 10 (1B) or 1 × 10 (10B) colony-forming units/d over an 8-wk intervention period. The primary outcome was the change in IBS severity scoring system (IBS-SSS) total score after 8 wk, while secondary and exploratory outcomes included abdominal pain severity, IBS related quality of life, stool and microbial profile, and perceived stress.

RESULTS

IBS-SSS was significantly reduced, after 8 wk, in participants receiving 1B (-128.45 ± 83.30; < 0.001) and 10B (-156.77 ± 99.06; < 0.001), compared to placebo (-58.82 ± 74.75). Further, a dose-ranging effect was observed, with a greater absolute reduction in the 10B group ( < 0.05). A reduction in sub-scores related to abdominal pain, abdominal distension, bowel habits, and quality of life was observed in both groups compared to placebo ( < 0.001). Further, 62.5% and 88.4% of participants administered 1B and 10B, respectively, were classified as stool consistency responders based on a reduction in diarrheal stool form, as compared to 26.3% in the placebo group ( < 0.001). In contrast, no significant shifts were observed in microbial diversity.

CONCLUSION

Lpla33 (DSM34428) is well tolerated and improves IBS symptom severity with a dose-ranging effect and a corresponding normalization of bowel habits in adults with IBS-D.