Introduction: The objective of this clinical trial was to assess the efficacy and safety of Flonivin BS (Bacillus Subtilis IP 5832) vs. placebo in treatment of patients with acute non-typhoid Salmonella gastroenteritis (ANSG), on adequate diet and parenteral rehydration therapy.
Material and methods: The clinical trial was conducted as a multicenter, controlled, randomized, double-blind, prospective clinical trial including 63 patients of both sexes, 20 to 52 years of age, with clinically, epidemiologically and microbiologically diagnosed ANSG, accompanied by diarrhea not longer than two days.
Results and discussion: Flonivin BS capsules (each capsule containing at least 1 billion of vegetative spores of Bacillus subtilis, strain IP 5832) were administered to 31 patients, while 32 patients received placebo (3 x 2 capsules daily) over a seven day period. Stool cultures were collected on days 7, 14, 21 and 28 for checking the carrier state. The efficacy criteria were based on determining the differences in duration of diarrhea and of the carrier state in Flonivin BS-treated group of patients as compared to the placebo-group. Statistical analysis was performed using Student's-test of proportions for small and large samples. The analysis of the number of patient-weeks by subgroups on days 7, 14, 21 or 28 of the trial in Flonivin BS- and placebo-groups has shown that the rate of patient-weeks of the carrier state was significantly lower in Flonivin BS-treated group as compared to the placebo-group, which was manifested in week 4 of the trial (p < 0.01). The analysis of the rate of positive findings in stool cultures in the groups treated with Flonivin BS vs. placebo by weeks of the confirmed carrier state has shown that Flonivin BS significantly reduces the rate of positive findings in stool cultures in the fourth week from the initiation of treatment (p < 0.05). No differences were noted in duration of diarrhea between the study groups (p > 0.05).
Conclusion: It has been concluded that a seven day treatment with Flonivin BS in patients with ANSG is of significance in prevention of a long-term carrier state, as it reduces the number of diseased that remain carriers in the third week after completion of treatment (p < 0.05). A prophylactic administration of Flonivin BS in patients with ANSG has a potential epidemiological significance due to a significant reduction in the number of patient-weeks of the carrier state in population of long-term carriers (p < 0.01).