Background: A probiotic mixture prevented epithelial barrier impairment in various experimental models. The objective was to evaluate its effects in patients suffering from IBS-D with confirmed leaky gut. Methods: IBS D patients with increased intestinal permeability measured by radionuclide tracers were enrolled in this pilot, open-label, prospective, interventional, single-center, Phase IV study. Patients received two capsules of a multistrain probiotic a day for 30 days and were evaluated by repeated intestinal permeability test, the Bristol Stool Scale, and patient-perceived quality of life and satisfaction. Results: Of the 30 enrolled patients (mean age: 42.1 [SD: 13.1] years; female: 60%), 27 completed the study (Full Analysis Set [FAS]), 18 had no major protocol violation (Per Protocol Set [PPS]). On D30, an improvement of intestinal permeability was observed in 81.5% of patients in FAS, normalization being observed in 37% of the participants (44% in PPS). Mean intestinal permeability was significantly decreased: baseline minus D30, 3.4 (95%CI: 1.7, 5.2); IBS-QOL Total score was significantly increased: D30 minus baseline, 8.0 (95%CI: 3.0, 12.9); stool consistency was significantly improved. On D15 and D30, 96.3% of patients claimed that their IBS symptoms had been satisfactory alleviated, and a significant improvement was reported for the following VAS-IBS items: Abdominal pain, Diarrhea, Impact of gastrointestinal problems in daily life. Compliance and tolerance were satisfactory. Conclusion: The multistrain probiotic tested may reduce intestinal permeability in a considerable proportion of patients and may improve abdominal pain, stool consistency, and quality of life. These results pave the way for larger, placebo-controlled clinical studies.

Ait Abdellah, S., Gal, C., Laterza, L., Velenza, V., Settanni, C. R., Napoli, M., Schiavoni, E., Mora, V., Petito, V., Gasbarrini, A., Effect of a multistrain probiotic on leaky gut in patients with diarrhea-predominant irritable bowel syndrome (IBS-D): a pilot study, <<DIGESTIVE DISEASES>>, N/A; (N/A): N/A-N/A. [doi:10.1159/000526712] [https://hdl.handle.net/10807/227056]

Effect of a multistrain probiotic on leaky gut in patients with diarrhea-predominant irritable bowel syndrome (IBS-D): a pilot study

Laterza, Lucrezia;Settanni, Carlo Romano;Schiavoni, Elisa;Mora, Vincenzina;Petito, Valentina;Gasbarrini, Antonio
2022

Abstract

Background: A probiotic mixture prevented epithelial barrier impairment in various experimental models. The objective was to evaluate its effects in patients suffering from IBS-D with confirmed leaky gut. Methods: IBS D patients with increased intestinal permeability measured by radionuclide tracers were enrolled in this pilot, open-label, prospective, interventional, single-center, Phase IV study. Patients received two capsules of a multistrain probiotic a day for 30 days and were evaluated by repeated intestinal permeability test, the Bristol Stool Scale, and patient-perceived quality of life and satisfaction. Results: Of the 30 enrolled patients (mean age: 42.1 [SD: 13.1] years; female: 60%), 27 completed the study (Full Analysis Set [FAS]), 18 had no major protocol violation (Per Protocol Set [PPS]). On D30, an improvement of intestinal permeability was observed in 81.5% of patients in FAS, normalization being observed in 37% of the participants (44% in PPS). Mean intestinal permeability was significantly decreased: baseline minus D30, 3.4 (95%CI: 1.7, 5.2); IBS-QOL Total score was significantly increased: D30 minus baseline, 8.0 (95%CI: 3.0, 12.9); stool consistency was significantly improved. On D15 and D30, 96.3% of patients claimed that their IBS symptoms had been satisfactory alleviated, and a significant improvement was reported for the following VAS-IBS items: Abdominal pain, Diarrhea, Impact of gastrointestinal problems in daily life. Compliance and tolerance were satisfactory. Conclusion: The multistrain probiotic tested may reduce intestinal permeability in a considerable proportion of patients and may improve abdominal pain, stool consistency, and quality of life. These results pave the way for larger, placebo-controlled clinical studies.
2022
Inglese
Ait Abdellah, S., Gal, C., Laterza, L., Velenza, V., Settanni, C. R., Napoli, M., Schiavoni, E., Mora, V., Petito, V., Gasbarrini, A., Effect of a multistrain probiotic on leaky gut in patients with diarrhea-predominant irritable bowel syndrome (IBS-D): a pilot study, <<DIGESTIVE DISEASES>>, N/A; (N/A): N/A-N/A. [doi:10.1159/000526712] [https://hdl.handle.net/10807/227056]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/227056
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