V. N. Chernobrovyy and I. G. Paliy evaluated the potential of Enterosgel therapy in the treatment of large intestinal dysbiosis in the adult patients [1]. Fecal microbiology revealed intestinal dysbiosis in all study subjects: increased counts of E. coli haemolyticus and cocci, as well as positive tests for Klebsiella pneumoniae, S. аureus, and P. vulgaris.

Clinical manifestations of large intestinal dysbiosis included abdominal flatulence, constipation, diarrhea, alternation of constipation and diarrhea, and periodic abdominal pain. The experimental group patients received conventional basic therapy (diet therapy, vitamin therapy, probiotics) and the intestinal adsorbent Enterosgel. Improvement and elimination of clinical symptoms occurred by the 4th or 5th day of therapy in 98% of the experimental group patients. Intestinal microbiota returned to normal in 100% of the patients after the treatment course, as demonstrated by microbiological examination.

Clinical evidences

Chernobrovyy VN, Paliy IG. [Use of the enterosorbent Enterosgel in therapy of intestinal dysbiosis]. Mystectvo likuvannja. 2003;5:74 (in Russian).

The use of Enterosgel® in the treatment of Helicobacter pylori

Tkachenko et al., 2016, assessed the efficiency and safety of using Enterosgel® in the treatment of Helicobacter pylori – associated diseases. Thirty patients with H. pylori-associated diseases of the upper GIT were included in the study. The average age of the patients was 45.6+10.5 years, 14 men and 16 women. The patients were divided in two groups: 1) the main group (n=15): treatment with Enterosgel® only, one dose of 22.5 g, three times a day after meal for three weeks; 2) control group: treatment – eradication therapy (omeprazoIe 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day for 7 days). Manifestation dynamics of gastrointestinal complaints was assessed using the standard questionnaire and Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. On comparison of the groups studied, statistically significant differences were found by the scales of GSRS questionnaire between the groups regarding diarrhoea syndrome: after the eradication therapy course, patients of Group 2 started experiencing diarrhoea syndrome, while in patients of Group 1, expression of diarrhoea syndrome decreased. Of 9 patients of Group 1 whose stool frequency was higher than 7 times a week, 4 patients experienced a tendency towards normalisation. Patients in Group 1 had a statistically significant decrease on the scale of dyspeptic complaints severity and reduction of the total score of measurements. Patients in Group 2 showed increased complaints of diarrhoea syndrome, the number of scores for the rest of the scales did not significantly change after a course of eradication therapy. After a course of treatment with Enterosgel®, positive clinical dynamics was observed in patients with H. pylori-associated gastroduodenitis. The administration of Enterosgel® decreased such symptoms as heartburn, regurgitation and excessive passage of flatus. Statistically significant differences between the two groups were noted for: the frequency of complaints of excessive flatus passage in group 1 decreased to a greater extent than in group 2; the frequency of complaints about the rumbling in the stomach, diarrhoea and abdominal pain decreased in group 1, while they increased in group 2. Clinical trials have demonstrated the safety and efficacy of Enterosgel®, administered as a monotherapy to treat patients with H. pylori-associated gastroduodenitis. Open

Tkach, 2011, studied the effectiveness of Enterosgel use in combined anti-Helicobacter therapy for patients with peptic ulcer disease. 60 patients (37 males and 23 females) aged from 18 to 60 years with H. pylori-positive peptic ulcers of stomach (12 patients) and duodenum (48 patients) were included in this open-label, parallel-group, comparative study. To assess the effectiveness of the eradication therapy combined with Enterosgel, the patients were randomly assigned in two groups. The experimental group was composed of 30 patients (25 with duodenal ulcer, and 5 with gastric ulcer) who received the 7-day triple eradication therapy combined with 10-day administration of Enterosgel. The triple therapy consisted of omeprazole (20 mg 2 times a day), clarithromycin (500 mg 2 times a day), and amoxicillin (1000 mg 2 times a day). Enterosgel was prescribed as 1 tablespoon 3 times a day (45 g/day), 1–2 hours before or after a meal. After finishing the basic course of the treatment, the patients continued to receive omeprazole 20 mg once a day for 2 weeks (with duodenal ulcer) and 3–6 weeks (with gastric ulcer). The control group consisted of 30 patients (23 patients with duodenal ulcer and 7 patients with gastric ulcer) who received only the 7-day triple therapy and a subsequent omeprazole treatment (20 mg once a day) for 2 weeks patients with duodenal ulcer and 3–6 weeks patients with gastric ulcer. All patients completed their treatment without interruption. No differences between the two groups were found in the speed of achieving positive dynamics in patients with duodenal ulcer. In patients of the experimental group with gastric ulcer, the clinical effect occurred faster, as the percentage of the patients with reduction or disappearance of clinical manifestations of the disease on day 28 of the treatment was significantly higher than in the control group (80% vs 71.4%, p < 0.05). Significant difference was observed in the rate of healing of gastric ulcers within 28 days of treatment. Complete healing of ulcers took place in 3 out of 5 patients of the experimental group (60%) with only in 3 out of 7 patients of the control group (42.8%) during the same period (p < 0.05). Administration of Enterosgel was accompanied by a significantly higher H. pylori eradication rate in patients with duodenal ulcer (96% vs 82.6% in the control group). No significant difference was observed in the rate between two groups of patients with gastric ulcer. No serious side effects were recorded during the treatment. In patients of both groups, the minor side effects were associated with the administration of clarithromycin and amoxicillin. The total number of patients with side effects was significantly lower in the group receiving Enterosgel than in the control group (33.3% vs 46.6%, p < 0.05). Symptoms such as abdominal bloating (16.6% vs 26.6%, p < 0.05), diarrhoea (16.5% vs 30%, p < 0.05), unpleasant metallic and bitter taste in the mouth (33.3% vs 46.6%, p < 0.05), and transient elevation of transaminases (3.3% vs 13.3%, p < 0.05) were significantly rarer in the experimental group rather than in the control group. More than one side effect was observed in 9 patients (30%) of the experimental group and in 14 patients (46.6%) of the control group (p < 0.05). Excellent and good treatment tolerance was observed in 21 patients (70%) of the experimental group and in 16 patients (53.3%) of the control group (p < 0.05). In other patients, the tolerance was assessed as satisfactory. The safety of treatment was assessed based on the dynamics in complete blood count and biochemical analysis of blood. No significant changes were noted except transient elevation of transaminases on day 7 of treatment. Transient hypertransaminasemia was observed in 1 patient (3.3%) of the experimental group and in 4 patients (13.3%) of the control group. Its appearance was attributed to the hepatotoxic effect of the antibiotics. Open

Zaytseva et al., 2009, evaluated the effectiveness of various regimens of triple therapy, including Enterosgel enterosorption for eradication of H. pylori in children with chronic H. pylori-associated gastroduodenitis (CGD), living in ecologically unfavourable areas. 46 children aged from 7 to 16 years with CGD associated with H. pylori were enrolled in the study. Patients were randomized into three groups depending on the choice of medication and its dosage. Patients in Group 1 (n = 15) received triple therapy for H. pylori eradication: iansoprazole (60 mg/day), clarithromycin (500 mg/day for children < 12 years and 1000 mg/day for children > 12 years) and nifuroxazide suspension (800 mg/day). Patients in Group 2 (n = 16) received triple therapy with the same medications as patients in Group 1. However, the dose of nifuroxazide was reduced to 400 mg/day. Patients in Group 3 (n = 15) received lansoprazole, clarithromycin and metronidazole in recommended doses according to age. All patients received Enterosgel, 1 tablespoon (15 g) once a day, 1–2 hours before a meal together with triple eradication therapy. The rationale behind the use of enterosorption is the ability of Enterosgel to bind in the gastrointestinal tract toxic substances of different origin and pathogens and eliminate them from the body. In this study patients were recruited from heavily industrialised regions with likelihood of heavy metal contamination. The best results were achieved using the treatment in Group 1 and in addition patients in this group showed decreased levels of manganese, nickel, chromium, lead and formaldehyde (p < 0.05–0.01). The authors recommended the use of Enterosgel to remove industrial toxicants, however it is difficult to interpret their data without having a control group for comparison, in which Enterosgel was not used. Open