The efficacy and safety of the cytomucoprotector gelatin tannate in the treatment of acute gastroenteritis in children

Abstract

Introduction. Acute gastroenteritis (AGE) is one of the leading causes of pediatric morbidity and mortality. The use of cytomuco-protectors that stabilize the intestinal barrier can increase the effectiveness of treatment.The aim is to determine the gelatin tannate (GT) clinical efficacy, safety and antiviral activity in AGE in children admitted to the hospital.Materials and methods. An open, prospective, randomized study included 52 children <7 years of age with AGE. The intervention group (n = 28) received GT, which was administered orally at 250 mg to children <3 years of age and 500 mg to children £ 3 years of age 4 times a day for 7 days. The severity of AGE (Vizikari scale: 10-14 points and CDC: 1-5 points) in parallel groups was significant. Standard treatment included rehydration and probiotic B. bifidum 1 (15 * 108 CFU / day in three divided doses). Antibiotic therapy (ABT) was received by 50% of children from each group. Fecal samples at screening and on the 7th day of treatment were examined in Real-time PCR with the determination of nucleic acids of rotaviruses A, noro-, adeno-, astro- and enteroviruses. The viral etiology of AGE was confirmed in 53.8%, salmonellosis - in 3.8% and campylobacteriosis - in 1.9% of patients.Results. GT reduced the risk of diarrhea on day 5 by 32% [95% confidence interval 14-50%] OR 0.25 [0.11-0.25] and by 14% [4-24%] by day 7. In the GT group, on day 7 of treatment, all patients had normal stool consistency. GT reduced the time for stool normalization by 1.3 days [0.2-2.3]. A more significant effect was obtained in patients with risk factors for insufficient treatment efficacy and in patients with inflammatory AGE requiring ABT. In those who received GT, a decrease in the concentration of viruses in feces was found, in the control - no statistical differences. The recurrence of AGE symptoms during hospital treatment was recorded with a frequency of 3.6% and 16.7%, respectively (p = 0.111).Conclusions. GT significantly reduced the risks of incomplete therapy effect by day 7 of treatment and the average positiveness of stool normalization. Trends in the antiviral action of GT and its positive effect on the incidence of nosocomial viruses.