The Effectiveness and Safety of Multi-Strain Probiotic Preparation in Patients with Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Controlled Study |
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Authors: | Barbara Skrzydł o-Radomań ska,Beata Prozorow-Kró l,Halina Cichoż -Lach,Emilia Majsiak,Joanna Beata Bierł a,Ewelina Kanarek,Agnieszka Sowiń ska,Boż ena Cukrowska |
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Affiliation: | 1.Department of Gastroenterology, Medical University of Lublin, Jaczewskiego 8, 20-950 Lublin, Poland; (B.S.-R.); (B.P.-K.); (H.C.-L.);2.Faculty of Medicine, Cardinal Stefan Wyszynski University, Wóycickiego 1/3, 01-938 Warsaw, Poland;3.Department of Pathomorphology, The Children Memorial Health Institute, Aleja Dzieci Polskich 20, 04-730 Warsaw, Poland; (J.B.B.); (E.K.); (A.S.) |
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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 {"type":"clinical-trial","attrs":{"text":"NCT 04662957","term_id":"NCT04662957"}}NCT 04662957). |
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Keywords: | irritable bowel syndrome probiotics Lactobacillus Bifidobacterium IBS-SSS IBS-GIS |
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