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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 with diarrhea (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 tests, 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]), and 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). The mean intestinal permeability was significantly decreased: baseline minus D30, 3.4 (95% CI: 1.7, 5.2); the IBS-QOL total score was significantly increased: D30 minus baseline, 8.0 (95% CI: 3.0, 12.9); and 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, and 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.
SUBMITTER: Ait Abdellah S
PROVIDER: S-EPMC10906476 | biostudies-literature | 2023
REPOSITORIES: biostudies-literature
Ait Abdellah Samira S Gal Caroline C Laterza Lucrezia L Velenza Venanzio V Settanni Carlo Romano CR Napoli Marco M Schiavoni Elisa E Mora Vincenzina V Petito Valentina V Gasbarrini Antonio A
Digestive diseases (Basel, Switzerland) 20220825 3
<h4>Background</h4>A probiotic mixture prevented epithelial barrier impairment in various experimental models. The objective was to evaluate its effects in patients suffering from IBS with diarrhea (IBS-D) with confirmed leaky gut.<h4>Methods</h4>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 f ...[more]