Experience of using the probiotic Bacillus clausii UBBC-07 in children of early age with acute watery diarrhea in the conditions of a hospital department

Abstract

Acute watery diarrhea in children remains an urgent problem in pediatrics due to its high prevalence and high mortality rates at an early age. Modern treatment protocols provide for a comprehensive approach to the treatment of patients. However, the main method of treatment of diarrhea - oral rehydration, does not allow for the stoppage of the progression of gastroenteritis, of the elimination of the imbalance of microflora and intestinal dysfunction. Such tasks can be solved thanks to the use of probiotics, which are recommended as a component of auxiliary therapy for children with acute infectious diarrhea.

Purpose - to conduct a comprehensive clinical and epidemiological analysis of the results of the use of the spore-forming probiotic Bacillus clausii (B. clausii) strain UBBC-07 (Lactiale Germina) in the complex treatment of hospitalized young children with acute infectious watery diarrhea syndrome.

Materials and methods. 85 children with acute infectious non-inflammatory diarrhea were comprehensively examined. 2 clinical groups were formed. The Group I - 50 hospitalized children (average age 3.1±0.4 years, the proportion of boys - 64.0%), who received 1 bottle of Lactiale Germina 1 time/day in complex treatment (5 ml=2×10⁹ CFU B. clausii endospores). The Group II included 35 patients (average age 2.4±0.4 years (p>0.05), the share of boys - 54.3% (p>0.05)); who received standard treatment according to existing standards. According to the main clinical characteristics, the comparison groups can be considered comparable.

Results. The analysis of the conducted studies established that the use of Lactial Germin increased the chances of a three-fold reduction in the frequency of bowel movements on the 4^th day (absolute risk increase (ARI) - 27.0%, relative risk increase (RRI) - 34.6 (95% CI: 25.4-44.8) with the minimum number of patients who need to be treated to obtain a positive result (MNP) - 2.9 (95% CI: 0.5-8.6), led to the absence of the symptom of vomiting already for the 3^rd day of inpatient treatment (ARI - 9.0%, RRI - 37.5 (95% CI: 28.0-47.7) with MNP - 2.7 (95% CI: 0.4-8.1), increased the chances of a lower need for long-term (≥3 days) parenteral rehydration (ARI - 12.9%, RRI - 13.7% (95% CI: 7.6-22.1) with MNP - 7.3 (95% CI: 2.9-14.3) and reduced the risk of needing to use antidiarrheal agents (relative risk - 3.2 (95% CI: 2.6-3.9) with an odds ratio - 7.1 (95% CI: 3,4-14,7)).

Conclusions. Food supplement Lactiale Germina (probiotic strain B. clausii strain UBBC-07) in the complex treatment of children with acute watery diarrhea is effective and safe with good tolerability and rapid rates of clinical recovery.

The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of the participating institution. The informed consent of the patient was obtained for conducting the studies.

No conflict of interests was declared by the authors.