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Article / Publication Details
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.
S. Karger AG, Basel
Article / Publication Details
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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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