Nutritional supplement for indigenous intestinal microflora: manufacturing, quality and effectiveness evaluation

Abstract

The pharmaceutical composition of a nutritional supplement, which has a profound effect on the maintenance and development of the indigenous intestinal microflora, has been scientifically proven. The nutritional supplement is obtained by combining the encapsulation technology with the pellet technology to ensure that the pharmaceutical composition remains intact and the product appeals to consumers. The combination of encapsulation and pellet technology is highly beneficial to the manufacturing process as the delivery of the ingredients, which are very different in absorption and penetration rates, is improved, controlled and becomes very site-specific, while at the same time offering even distribution. The quality of the nutritional supplement has been proven and the product complies with the compulsory sanitary-hygienic and sanitarytoxicological regulations for dietary supplements. Clinical trials for the new nutritional supplement were performed to ensure the safety and the effectiveness of the product. Sixty volunteers aged from 33 to 72 were involved in the clinical trials. All of the volunteers were diagnosed with different intestinal microbiota disorders, among them a decreased number of microbial symbionts (bifidobacteria, lactobacilli, Escherichia coli (Lac +), the presence of Klebsiella pnenmoniae and opportunistic pathogens like Candida alticans. Patients with intestinal microbiota disorders were prescribed to take 1 capsule of the nutritional supplement twice a day for a period of 30 days together with other medicine prescribed to improve the biocenosis. Having taken part in the clinical trials, nearly 90% of patients, who had previously experienced such symptoms as bloating, gas, different abdominal pains, cramping, diarrhoea and constipation, demonstrated microbiota restoration, along with the overall health improvement. Considering the findings of the clinical trials, it should be noted that the use of ‘Panbiom’ nutritional supplement can play an important role in keeping the immune system healthy, with short chain fatty acids becoming the main focus of attention. Short chain fatty acids are the key to stimulating the immune response, as they support the regulatory T cells, prevent pathological changes and lessen the symptoms. The nutritional supplement composition and the manufacturing process were developed and tested at the scientific research-to-production facilities of Art-Life Scientific Production Association in Tomsk. All the mandatory documentation was obtained and fully complies with the requirements for nutritional supplements.