The Effectiveness and Safety of Multi-Strain Probiotic Preparation in Patients with Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Controlled Study

Barbara Skrzydło-Radomańska, Beata Prozorow-Król, Halina Cichoż-Lach, Emilia Majsiak, Joanna Beata Bierła, Ewelina Kanarek, Agnieszka Sowińska, Bożena Cukrowska, Barbara Skrzydło-Radomańska, Beata Prozorow-Król, Halina Cichoż-Lach, Emilia Majsiak, Joanna Beata Bierła, Ewelina Kanarek, Agnieszka Sowińska, Bożena Cukrowska

Abstract

The aim of this randomized double-blind placebo-controlled study was to evaluate the effectiveness and safety of multi-strain probiotic in adults with diarrhea-predominant irritable bowel syndrome (IBS-D). The patients were randomized to receive a mixture of Lactobacillus, Bifidobacterium, and Streptococcus thermophilus strains or placebo for eight weeks. Primary endpoints included changes in symptom severity and improvement assessed with the IBS Severity Scoring System (IBS-SSS) and Global Improvement Scale (IBS-GIS). The probiotic in comparison with placebo significantly improved the IBS symptom severity (the change of total IBS-SSS score from baseline ‒165.8 ± 78.9 in the probiotic group and ‒105.6 ± 60.2 in the placebo group, p = 0.005) and in the specific scores related to the severity of pain (p = 0.015) and the quality of life (p = 0.016) after eight weeks of intervention. The probiotic group indicated an improvement in symptoms with the use of the IBS-GIS compared with the placebo group after four (p = 0.04) and eight weeks (p = 0.003). The occurrence of adverse events did not differ between study groups. In conclusion, the multi-strain probiotic intervention resulted in a significant improvement in IBS symptoms evaluated with the use of both IBS-SSS and IBS-GIS scales. The results suggest that the studied probiotic preparation is well tolerated and safe and can offer benefits for patients with IBS-D. (registration number in Clinicaltrials.gov NCT04662957).

Keywords: Bifidobacterium; IBS-GIS; IBS-SSS; Lactobacillus; irritable bowel syndrome; probiotics.

Conflict of interest statement

B.S.-R. has served as a speaker for Polpharma, Krka, Takeda, Bayer, Promed, and Alfasigma. B.C. conducted research financed by Danone, Biomed S.A., and conducted lectures sponsored by Nutricia, Danone, Mead Johnson, Bayer, Aurovitas, Polpharma, and Biomed S.A.

Figures

Figure 1
Figure 1
Study protocol flowchart.
Figure 2
Figure 2
The percentage of patients with an improvement in IBS symptoms evaluated with the use of the IBS-SSS after probiotic treatment lasting 4 and 8 weeks. The total IBS-SSS score (a) and domain-specific scores related to the severity of pain (b), frequency of pain (c), dissatisfaction with bowel habit (d), severity of flatulence (e), and quality of life were analyzed (f). An improvement was defined as at least a 30% decrease in scores compared with baseline scores. NS = no significance (p > 0.05). Statistical analysis performed with the use of Fisher’s exact test.
Figure 3
Figure 3
The effect of probiotic intervention on global IBS symptoms evaluated with the use the IBS-GIS. The IBS-GIS score (a) and an improvement in global IBS symptoms (b) were evaluated after 4 and 8 weeks of treatment. The results are presented as means ± SD of the IBS-GIS score (a) or the percentage of patients with an improvement in IBS symptoms (b). IBS-GIS scores >4 points indicated an improvement.

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