Efficacy and Safety Evaluation of Gastrokur Dietary Supplement in Combination with Pantoprazole in Patients with Helicobacter pylori

Abstract

The results of a clinical study of the efficacy and safety of taking a dietary supplement Gastrokur in combination with pantoprazole in patients with Helicobacter pylori are presented. Material and methods. 10 patients with H. pylori infection confirmed according to 13C-urease respiratory test for four weeks received the dietary supplement Gastrokur two capsules three times a day in combination with pantoprazole 40 mg once a day. A special condition was the compliance with Gastrokur temperature regime of storage from +40 to +100 С. The efficacy of eradication was evaluated using a 13C urease breath test 30 days after completion of treatment. Results. H. pylori eradication was achieved in two out of 10 (20%) patients according to the ITT criterion and in two out of nine (22.2%) patients according to the PP criterion. By the 14th day of therapy, 80% of patients had completely stopped symptoms of dyspepsia with the effect remaining for a month after the end of therapy. During the first two weeks of therapy, three patients had bloating, five had mushy stools no more than three times a day. These phenomena were not pronounced and did not require interruption of treatment. One patient dropped out of the study due to an exacerbation of pink lichen on the 21st day of therapy, which independently passed two days after discontinuation of treatment. Conclusion. A course of therapy with a biologically active food supplement Gastrokur in combination with pantoprazole led to the eradication of H. pylori in 20%. Against the background of therapy, a good positive clinical dynamics was observed. No serious adverse events have been reported, with the exception of an exacerbation of pink lichen in one patient.