Administration of the metabiotic complex based on Bacillus subtilis in treatment regimens for inflammatory bowel diseases: focus on intestinal barrier permeability

The aim of the study. To determine the efficacy and safety of using the metabiotic biologically active food supplement «Bactimunal», including a combination of biologically active metabolites of Bacillus subtilis (B. subtilis) strain SA44 and short-chain fructooligosaccharides (scFOS, polyfructosans), prescribed additionally in treatment regimens for patients with inflammatory bowel diseases (IBD). Materials and methods of the study . 80 patients with IBD were examined, the average age was 41.1±11.14 years, of which 40 (50%) patients with UC, and 40 (50%) with CD, 38 (47.5%) men, 42 (52.5%) women. All patients underwent assessment of clinical symptoms of the disease, venousblood and fecal samples were collected to assess the serum level of trefoil factor (TFF), lipopolysaccharides (LPS), fecal zonulin (FZ) and fecal calprotectin (FC). 40 patients with IBD (20 patients with UC and 20 patients with CD) received basic therapy. 40 patients with IBD (20 patients with UC and 20 patients with CD) received the metabiotic Bactimunal 1 capsule 2 times a day in addition to the basic treatment regimens for 28 days. The observation period for patients in both groups was 28 days, at the end of the observation, the severity of clinical symptoms and intestinal permeability markers (TFF, LPS and FC) were re-evaluated. Statistical data processing was performed using the SPSS (Statistical Package for the Social Sciences) program. Values of p<0.05 were accepted as statistically significant. Results of the study . In UC, abdominal pain syndrome in the group of patients taking Bactimunal was noted by 15 (75%) patients before the start of adjuvant therapy, after – 9 (45%) (χ2 =2.604, p=0.05), in the group without Baсtimunal, abdominal pain was noted by 12 (60%) patients before treatment and 7 (35%) patients after (χ2 =0.004, p=0.48). In the group of patients with CD who additionally received Bactimunal, all 20 (100%) patients noted abdominal pain at the beginning of the observation, after 28 days, abdominal pain was felt by only 11 (55%) patients (χ2 =9.176, p=0.002). At the beginning of the observation, in the group without Bactimunal, abdominal pain was felt by 19 (95%) patients, and after 28 days it persisted in 18 (90%) patients. In patients with IBD who did not receive the metabiotic, the average pain intensity score before treatment was 2.55 points, after – 1.39 points (p>0.05). In IBD patients who received adjuvant therapy with Bactimunal, the average pain scores statistically significantly decreased – from 2.65 points at the beginning of the observation to 0.68 points after 28 days (p=0.025). During dynamic control after 28 days, the frequency of bowel movements decreased in both groups (mean frequency 2.74±0.84 bowel movements/day), statistically significant differences between the groups receiving and not receiving Bactimunal were not revealed (p>0.05). In patients who additionally took Bactimunal, the decrease in the scores of urgencies to defecate in both UC and CD was statistically significantly greater than in patients who did not receive the dietary supplement. In patients with IBD from the group receiving additional therapy with Bactimunal, a statistically significant decrease in the frequency of occurrence and severity of flatulence was noted after 28 days compared to patients in the group not receiving the dietary supplement. In all patients with IBD laboratory markers reflecting the state of the mucosal barrier of the gastrointestinal tract were significantly elevated upon inclusion in the study. In IBD patients additionally receiving Bactimunal in their treatment regimens, a decrease in the average TFF level was registered after 28 days of observation. When assessing the LPS indicators, multidirectional changes were obtained. Normalization of FC concentration occurred in 32 (80%) IBD patients taking Bactimunal, compared with 8 (20%) patients who did not receive Bactimunal as adjuvant therapy (OR=1.5; 95% CI 1.4–3.7; p=0.05) (Table 5). In patients with mild IBD, a decrease in the FC level was observed in 62.5% patients taking Bactimunal, in another group of patients, a decrease in the FC level was noted in 38.5% patients (OR=1.6; 95% CI 1.1–2.49; p=0.03). Conclusions. Metabiotic therapy, prescribed in addition to the basic one, is promising in patients with IBD. The results of the study suggest that in the case of mild IBD additional therapy with Bactimunal can contribute to modulation of the permeability of the intestinal barrier and reduction of the inflammatory process.