Medical trials show, there was shortening of exacerbation period and complete relief of morphological elements on the skin and the achievement of clinical remission was observed in average on the 8th day from the start of therapy to receive Enterosgel combined with the standard conventional treatment.

ENTEROSGEL® is effective an adjuvant (ancillary) treatment for allergies with gastrointestinal symptoms to other standard conventional treatment for acute enteric intestinal complaints in children and adults in the following conditions:

  • Pediatric atopic dermatitis complicated by fungal infection.
  • Food allergy treatment.
  • Large intestinal dysbiosis treatment in children and adult patients.
  • Treatment of children with pyelonephritis.
  • Bronchial asthma and atopic dermatitis treatment.
  • Skin allergies treatment.
  • Seasonal allergy treatment.
  • Mild to moderate stable bronchial asthma treatment.
  • Chronic urticaria treatment.
  • Stable atopic dermatitis treatment.
  • Polyvalent allergy treatment.
  • Indigestion treatment.
  • Chronic fatigue syndrome treatment.
  • Chronic uveitis treatment
  • Chronic keratitis and recurrent stomatitis treatment.
  • Atopic bronchial asthma treatment.
  • Dermal-respiratory syndrome treatment.

Clinical Evidences

Sheiman et al., 2004, demonstrated the effectiveness of Enterosgel in the treatment of children with pyelonephritis. They established that the inclusion of Enterosgel in a conventional treatment programme promoted normalisation of plasma toxicometry parameters. In patients treated with Enterosgel a significant reduction in the number of middle-weight molecules and decreased toxicity of these molecules (free and protein-bound in the blood circulation) was registered as compared with the control group (cited in Nagornaya et al., 2010). Open

Boyarskaya et al., 2008, assessed the effectiveness of Enterosgel in the treatment of intestinal dysbiosis in children with burn disease. They examined 68 children aged from 1 year to 7 years. All patients had suffered extensive burns associated with increased risk of wound contamination with pathogenic microflora. Enterosgel was administered to the experimental group of patients as part of a combination therapy programme. The use of Enterosgel helped to restore anaerobic resident intestinal microflora in 20–40% patients and aerobic and facultative aerobic in 40–60% patients (cited in Nagornaya et al., 2010).

Chernobrovyi et al., 2003, evaluated the potential of Enterosgel treatment of large intestinal dysbiosis in adult patients. The experimental group of patients received conventional basic therapy (diet therapy, vitamin therapy, probiotics) and Enterosgel. Improvement and elimination of clinical symptoms occurred by the 4-5th day of treatment in 98% of the experimental group patients. Intestinal microbiota returned to normal in 100% of the patients after the treatment course (cited in Nagornaya et al., 2010).

Melnykov et al., 2010, reported the results of the clinical study of the efficacy of Enterosgel in the treatment of food allergy. The experimental group included 67 patients aged from 12 to 50 years who had food allergy and a history of various manifestations thereof ranging from mild erythema to angioedema. Patients with any evidence of a possible familial history of the disease were excluded from the study. The control group included 10 practically healthy volunteers aged from 17 to 45 years. The experimental group patients were administered conventional treatment in combination with Enterosgel: desloratadine, calcium gluconate, and Enterosgel 15 g 2 times a day for 10 days. Healthy subjects were given a course of Enterosgel, 15 g 2 times a day for 10 days. 33 patients presented with skin manifestations of food allergy, which developed 10 to 50 minutes after a meal and ranged from perioral erythema to generalised urticaria and subsequent angioedema. 24 patients also complained of facial angioedema, which had begun with swelling of the lips, soft tissues under the eyes, and the tip of the nose. Angioedema usually lasted 2 to 3 days and was eliminated within 10 to 20 hours in the patients administered antihistamine medication and Enterosgel. 10 patients had gastrointestinal complaints, including reactions to food. As a result of treatment, patients with food allergy had a statistically significant reduction in the content of the pro-allergic cytokine IL-5 and IgE; however, the IFN-γ level did not change significantly. Both IgE and IFN-γ remained at significantly higher level than in the healthy group. The authors of the study did not run the control group of patients without Enterosgel, so the results of this work are difficult to interpret in terms of the therapeutic value of enterosorption treatment except for the fact that no side-effects of its use were mentioned. Open

Malanicheva et al., 2013, studied the effect of Enterosgel on the treatment of pediatric atopic dermatitis complicated by fungal infection. All children with atopic dermatitis included in the study had continuous type of development of their disease with resistance to the anti-allergic therapy. 68% of the examined children had moderately severe course of the disease, whereas 32% of them showed severe course. 47% of the children had food allergen sensitisation, 25% had indoor allergen sensitisation, and 28% had polyvalent sensitisation. The experimental group 1 included 40 children with complicated forms of atopic dermatitis with fungal infection. They received Enterosgel combined with the standard conventional treatment. Enterosgel was administered for 2–3 weeks according to the age-related dosage. The children under 5 years were administered 1 teaspoon 3 times a day (15 g/day). Those between 5 and 14 years were administered 2 teaspoons 3 times a day (30 g/day). The patients over 14 years of age were administered 1 tablespoon 3 times a day (45 g/day). The control group 2 included 20 children who received the conventional treatment alone. The conventional treatment included: hypoallergenic diet; antihistamines; combined anti-inflammatory and antifungal topical medications; good daily skin care with special hypoallergenic skin cleansers and moisturisers; systemic antifungal drugs when indicated. The overall therapeutic effectiveness reached 87.5% in the experimental group and 65% in the control group. On average, SСORAD index reduced 4.5 times (from 54 to 12 points) in the experimental group, and 3 times in the control group (from 55 to 18). There was marked reduction in the duration of exacerbation in patients who received experimental treatment compared to the patients who received conventional treatment only (14.2 ± 1.7 vs 26.3 ± 1.8 days, respectively). Complete remission with disappearance of manifestations on skin was achieved around 12–16 days of the treatment vs 24–28 days in the control group. Those exacerbations which were observed after the treatment with combination therapy using Enterosgel were characterised by lesser severity of the clinical manifestations on skin. They showed smaller area covering the lesions, decrease in pruritus (skin itch) and inflammatory activity, reduced duration of relapse.

Baranov et al., 2013, studied the efficacy of Enterosgel in the treatment of children with bronchial asthma and atopic dermatitis. This study enrolled 60 children diagnosed with bronchial asthma. The experimental group was composed of 40 children who were administered Enterosgel in accordance with the algorithm designed by the authors. The control group consisted of 20 children. The two groups were comparable with regard to gender, age, and severity of clinical manifestations of asthma. All patients were given bronchodilators (methylxanthines and beta-agonists); 7 patients suffering from severe bronchial asthma received inhaled corticosteroids, while the rest were administered cromoglicic acid. The children aged between 2.5 and 5 years were administered 1 teaspoon of Enterosgel 3 times a day (15 g/day), the children over 5 years of age were given 1 tablespoon 3 times a day (45 g/day), 2 hours before or after a meal. The study was preceded in the experimental group by a 7-day control period, when the patients were followed up without receiving Enterosgel. Improvements were first observed on the 3rd day of Enterosgel treatment: choking sensations had ceased, the skin syndrome manifestations were not observed anymore, and gastrointestinal function had improved. The obstructive syndrome was clinically eliminated in 50% of study subjects by the 5th day of Enterosgel treatment. Normalisation of respiratory function occurred by the 14th day of treatment, while the patients with severe bronchial asthma experienced this normalisation by the third week of Enterosgel treatment. Along with the improvement of the main symptoms of bronchial asthma, the patients had their abdominal pain relieved and stools normalised. In the children with atopic dermatitis, the skin syndrome became significantly improved after a mean of five days of Enterosgel treatment. A complete remission was achieved by the 10th day in 85% of subjects. The analysis of study results demonstrated a significant improvement in the clinical course of bronchial asthma and concomitant conditions in the patients treated with Enterosgel, as compared with the control group. The obstructive syndrome was relieved in the experimental group 7 to 10 days earlier than in the control group. As a result of Enterosgel treatment, all patients had their dyspepsia relieved and gastrointestinal function improved. The authors however have not presented more detailed information about their study. The statistical significance of the results has not been presented.

Bystron et al., 2010, presented the results of his study of the role of Enterosgel in the integrated treatment of allergic diseases in adults. This study involved 24 patients (10 men and 14 women aged from 2 to 80 years, average age is 43.1) diagnosed with mild to moderate stable bronchial asthma (6 patients), chronic urticaria (7 patients), stable atopic dermatitis (6 patients) and 5 patients with a different diagnosis (1 patient with polyvalent allergy and indigestion, 1 patient with food allergy, 2 patients with chronic fatigue syndrome and 1 patient suffering from chronic uveitis, chronic keratitis and recurrent stomatitis). A point-based assessment was carried out during 21 days prior to the commencement of Enterosgel application (control group), and further during 21 days of regular taking of Enterosgel (experimental group). Patients were randomised to groups according to inclusion and exclusion criteria. After the end of the treatment, patients were provided with a questionnaire regarding their general impression of taking the enterosorbent. There was only 1 patient who demonstrated a refusal to take Enterosgel, who also persisted after the dosage and taste of the drug had been changed, and therefore the treatment was stopped. 5 patients did not report any changes in their health condition. 17 patients (74%) evaluated the Enterosgel treatment as beneficial, which was manifested as an improvement of digestion, relieving symptoms of indigestion, normalization of stool, improvement in the itching condition, alleviation or reduction of fatigue, improvement in sleep quality, improvement in breathing, relieving symptoms of allergic rhinitis, reduction of food allergy symptoms. Enterosgel has demonstrated safety and high tolerability. Adverse effects were reported in three patients: vomiting, in 1 patient the Enterosgel treatment was terminated prematurely after 3 days of application with no improvement after reduction of dosage and change of the taste; sensation of abdominal bloating in 1 patient; occasional myalgia and arthralgia in 1 patient. In both latter cases the treatment continued. It has been concluded that statistically significant improvement in the clinical scores, according to point-based assessment, proves the clinical efficacy of Enterosgel, concomitantly with standard treatment in patients, with bronchial asthma, chronic urticaria and other examined immune pathological conditions (polyvalent and food allergy, chronic fatigue syndrome). Open

Basieva et al., 2005, presented the results of their study on the use of enterosorption in the treatment of atopic bronchial asthma in the experimental group of 57 patients aged from 17 to 69 years who received conventional asthma therapy and Enterosgel. The control group was composed of 53 patients who received conventional therapy alone. They reported that the dyspepsia associated with food allergy was eliminated with Enterosgel treatment. The inclusion of the Enterosgel in the treatment programme allowed significant improvement in the manifestations of atopic dermatitis, such as pruritus, infiltration, and lichenification. Another finding was marked limitation of the skin lesion. Respiratory function demonstrated a 24.4% improvement in test results in the experimental group vs 17.1% in the control group (p < 0.005). The experimental group had earlier, as compared with controls, normalisation of body temperature, heart rate, as well as improvement or elimination of dyspnea and sweating. The patients on Enterosgel treatment had their subjective symptoms of intoxication, including general weakness, easy weariness on physical exertion, decreased appetite, impaired power of concentration, and irritability, decreased as early as by the 5-6th day of treatment. The results of the study however lacked details in this presentation.

Chorna et al., 2009, studied the effectiveness, tolerability, and safety of Enterosgel in the treatment of children with dermal-respiratory syndrome. The study included 56 children aged from 3 to 17 years and suffering from dermal-respiratory syndrome. 27 children were given Enterosgel as part of their combination therapy with conventional treatment, and Control group receiving conventional therapy only included 29 patients. All children aged over 5 years underwent allergological examination. The dermal- respiratory syndrome had become exacerbated because of domestic allergens, plant pollen, house dust, or use of medicines (most commonly antibiotics). Food allergy was observed in more than one-third of all evaluated children, and the overwhelming majority of them had multiple allergies. Inclusion of the intestinal adsorbent Enterosgel in the combination treatment programme promoted fast regression of the manifestations of dermal-respiratory syndrome resulting in: reduction of rash and skin oedema (85%) by the 5th day of the combination therapy; improvement of dyspepsia: normalisation of stools, elimination of nausea and vomiting.

The children in the control group had less improvements in the dermal-respiratory syndrome; some improvements were achieved only in 27.6% of patients. Relief of the symptoms of dermal-respiratory syndrome, abdominal syndrome, and dyspepsia were achieved as late as on the 7th or 8th day of treatment. All children tolerated Enterosgel therapy well. No patients experienced adverse reactions or refused to have this treatment.

Malanicheva et al., 2016, studied the efficiency of Enterosgel in correction of systemic endotoxemia in children with atopic dermatitis (AD). The study involved 30 children with AD aged 10 to 17 who entered the main group. Clinical AD structure: children with erythematous-squamous form – 40% (n = 12), lichenoid form – 60% (n = 18). Activity of skin process of II degree was diagnosed in 12 patients (40%), III degree – in 18 patients (60%). Moderate course of the disease was observed in 20 children (67%), severe – in 10 patients (33%). To evaluate enterosorption effectiveness of Enterosgel, the patients were divided into 2 groups. The study group included 16 children with AD treated with Enterosgel in the complex therapy for 14 days at the following doses: children aged 10-4 years – 1 dessert spoon 3 times a day (30 g), over 14 years – 1 tablespoon 3 times per day (45 g). The control group included 14 children treated with traditional anti-allergic drug therapy without Enterosgel. Antiallergic therapy did not differ in both groups and included hypoallergenic diet, antihistamines, external anti-inflammatory drugs, medical and cosmetic skin care. The use of Enterosgel led to a 12-fold decrease in the level of endotoxaemia (measured by the level of endotoxin in blood plasma), from 0.142 to 0.012 u/ml vs 6-fold decrease in the control group, from 0.139 to 0.023 u/ml (p<0.05). Overall therapeutic effect in the study group was 87.5% (n = 14) vs 64.3% (n = 9) in the control group. 10 patients (62.5%) had clinical improvement, (vs 6 patients or 42.9% in the control group) and in 4 patients (25%) there has been a considerable improvement of the skin process vs patients (21.4%) in the control group. Lack of effect was observed in 2 patients (12.5%) vs 5 patients (35.7% in the control group). Open

Paramonova et al., 2015, studied the effectiveness of Enterosgel in the complex therapy of children with AD. 46 children, aged between 3 and 12 years, were divided in two groups: Group 1 of 32 children, received Enterosgel along with standard anti-allergic therapy for 2 weeks. Group 2 of 14 children (control) received the standard treatment without enterosorbent. It was found that in a study group of children the overall therapeutic effect was 84.5% (27 children). Of these, 65.6% of patients (21 children) had full clinical recovery. In 23% (7 children) significant improvement on the part of the skin process. The lack of effect was observed in 12.5% of patients (4 children). There was shortening of exacerbation period and complete relief of morphological elements on the skin and the achievement of clinical remission was observed in average on the 8th day from the start of therapy. SCORAD index decreased on average 4-fold, from 57 up to 14 points. Among the control group of patients overall therapeutic effect was 57% (8 children). Of these, 50% of patients (4 children) had full clinical recovery and in 50% (4 people) there was a significant improvement on the part of the skin process. The lack of effect was observed in 43% of patients (6 children). SCORAD index decreased by 2.4 times, from 53 to 22 points. The achievement of clinical remission was observed in average on the 16th day from the start of therapy.

Zenokhov et al., 2010, assessed the efficiency of enterosorption using Enterosgel in the treatment of chronic urticaria, CU. 29 patients (mean age 45.9 ± 7.5 yrs), of about 7 years duration of the disease have been included in study. All were receiving antihistamines. Clinical outcome measurements (blood chemistry, gastroduodenoscopy, abdomen ultrasound, questionnaire of quality of life) before and after management were analysed in the treatment group (15 patients received Enterosgel for 2 weeks, 45 g daily) and the control group (15 patients received only nonsedative antihistamines therapy). After enterosorption more than half patients had normalised blood chemistry. In these patients the disappearance of cholestasis and biliary dyskinesia and reduction of duodenogastric reflux were noted. Before treatment the patients in both groups had very high score of itching, 3.5 (a scale from

0 (no) to 4 (max)).There was significant reduction in itching and size and the number of urticaria elements in enterosorbent group (p < 0.05). Quality of life in CU patents was associated with decreased cognitive performance, restriction of contacts to colleagues and friends, poor concentration at work. The patients had irritability and more half of patients often had agitation. Quality of life statistically significantly increased in the enterosorbent group. It has been connected with decrease in the needs in antihistamines and improvement of sleep quality, social and work related activities, reduction of tension, irritability, anxiety.

The results achieved in the experimental group however were not explicitly compared with the control group.