Effect of a Multistrain Probiotic on Leaky Gut in Patients with Diarrhea-Predominant Irritable Bowel Syndrome: A Pilot Study

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.

Keywords: Intestinal permeability; Irritable bowel syndrome; Leaky gut syndrome; Probiotics; Quality of life.

Fig. 1

Study flow diagram.

Fig. 2

Change in intestinal permeability assessed with radionuclide tracers. a Proportion of patients with normalized and abnormal permeability in the FAS and PPS on day 30 compared to screening. Measures were expressed as percentages of the ingested dose of tracer and considered indicative of normal permeability when urinary excretion was less than 3% of the orally administered dose [37]. b Decrease in intestinal permeability between screening and day 30 in the FAS and PPS (mean ± SD; Diff, difference).

Fig. 3

Changes in mean scores for the seven items of the VAS-IBS between baseline and days 15 and 30. Note: the question was “How have you been feeling during the past 2 weeks concerning…?” for item 1 to item 6 and “How much/little have your gastrointestinal problems influenced your daily life over the past 2 weeks?” for item 7.