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New probiotic for children from the first days of life registered in Russia

Currently, the attention of doctors from various specialties is increasingly drawn to probiotics - living microorganisms which, when prescribed in sufficient quantities, have a positive effect on human health.

The use of probiotics in clinical practice has a fairly strong evidence base: thousands of randomized controlled trials have been performed, meta-analyzes have been performed to assess the efficacy and safety of probiotics for both prevention and treatment of infectious and non-infectious diseases, and the results of these studies are very promising.

Probiotics are not only the subject of extensive scientific research, but also an important product on the world market. Today, hundreds of probiotic food products, biologically active food additives and drugs containing various strains of probiotic microorganisms are available to a wide range of consumers, helping to solve a wide variety of problems. health. But the logical question arises as to which of the probiotics is best used in a particular clinical situation, for example in children from the first months and even days of life or in adult patients; which drug to prescribe for therapeutic purposes and what to use prophylactically; favor foods enriched with probiotics, or opt for biologically active food additives or probiotics?

In February 2009, the drug Bifiform Baby (Ferrosan A / S, Denmark) containing Bifidobacterium lactis BB-12 (was registered as a biologically active food supplement in USA ) 109 CFU in a single dose) and Streptococcus thermophilus TH-4 (108 CFU in a single dose) (State registration certificate No. 77.99.23.3. U.1295.2.09 of 02.13.2009). This probiotic suspension is designed to restore the balance of the intestinal microflora in children from the first days of life. Bifiform Baby is available in bottles containing 6.9 ml of an oil solution, sealed with a lid containing 160 mg of powder; when mixing the contents, 7 ml of suspension are obtained for oral administration. The bottles are supplied complete with a dosing pipette. The drug can be used in children from the first days of life and adults in a single dose (0.5 ml) once a day with meals for 10 days or more.

Bifidobacterium lactis (BB-12) is one of the most studied probiotic strains of microorganisms with an obvious beneficial effect on human health [1]. BB-12 is found in the natural intestinal biofilm in healthy people and offers resistance to colonization (i.e. resistance to colonization of the intestine by pathogenic microorganisms). These are the bifidobacteria which are the predominant microorganisms which inhabit the intestines of breastfed children from 1-2 weeks of life. Infant formula enriched with B. lactis, have been used for over 15 years in 30 countries.

Streptococcus thermophilus TH-4 (or thermophilic streptococcus) is the only type of thermophilic lactic acid cocci regulated by the American GOSTs to be used as an input in the production of yogurt, sour cream, ryazhenka and certain types of cheese. It should be noted that S. thermophilus absorbs and processes lactose and, in this regard, is effective in lactase deficiency; It has an acidifying effect, thus providing a bactericidal effect against pathogenic microorganisms; It is also able to synthesize and secrete polysaccharides, which makes the nutrient mixture denser and helps to prevent and treat regurgitation.

B. lactis and S. thermophilus has been used in the dairy industry since 1984. For 25 years of use, no data on poor tolerance and the occurrence of effects undesirable when using these strains of microorganisms has been obtained. BB-12 and S. thermophilus have the so-called GRAS status (generally considered to be safe), which means international recognition of their safety and allowing their unlimited use in the food and pharmaceutical industries, as well only safe use in children from the first days of life [2].

According to the nutrition committee of the European Society of Gastroenterology, Hepatology and Pediatric Nutrition - ESPGHAN, the use of probiotics in neonatology and early childhood has three important advantages [3]:

The efficacy of the combination of probiotic microorganisms B. lactis BB-12 and S. thermophilus TH-4 has been demonstrated in a number of clinical studies, whose results have shown that BB-12 + S. thermophilus contribute to the prevention of diarrhea caused by rotavirus and increase the increase in body weight of infants [4].

In 1994, in a double-blind, randomized, placebo-controlled study of 55 infants and children aged 5 to 24 months, B. lactis BB-12 and S. thermophilus TH-4 prevents the development of nosocomial diarrhea in hospitalized children with chronic diseases. Thus, when using preparations containing the above two microorganisms, the incidence of acute diarrhea and the release of rotovirus from the intestine have been significantly reduced [5].

In 2004, the results of a double-blind, randomized, placebo-controlled study of 188 healthy children aged 3 to 24 months showed that the inclusion of B. lactis and S. thermophilus in the composition of the milk mixture provides a statistically significant decrease (p less than 0.001) in the number of intestinal colic episodes in children receiving probiotics compared to the control group, and also reduces the frequency of antibiotic use in the probiotic group (p less than 0.001). This study also demonstrated good tolerance and a favorable safety profile for B. lactis and S. thermophilus, applied on average for 210 days [6].

According to the results of a meta-analysis of 6 placebo-controlled studies in children (n = 766), in which the efficacy of Lactobacillus rhamnosus, Saccharomyces spp., Bifidobacterium lactis and Streptococcus thermophilus, the use of probiotics has been shown to reduce the risk of antibiotic-associated diarrhea by 28.5% to 11.9 % (relative risk 0.44) [7].

The use of probiotics is effective in preventing the occurrence of necrotizing enterocolitis (NEC) in newborns, a serious illness that still remains one of the main causes of death in premature babies with very low birth weight. According to various authors, NEC develops in 20 to 28% of these children. In a randomized, placebo-controlled study in 2005, it was shown that the incidence of NEC in premature babies weighing less than 1,500 g who received a mixture of probiotics (B. infantis, S. thermophilus and B. bifidus), was significantly lower than in the placebo group (4% vs 16.4%; p = 0.03). In addition, in children receiving probiotics, a less severe course of ECN has been observed if it occurs. In the probiotics group, there was no case of NEC with a fatal outcome, while in the control group, 15 children (21%) died of NEC [8].

Thus, the efficacy and safety of the probiotic microorganisms B. lactis BB-12 and S. thermophilus TH-4 is proven not only by more than 20 years experience in the food industry, but also through the results of controlled clinical trials. As a result, the new two-sided baby probiotic containing these microorganisms can serve as an effective, safe and practical means of restoring the balance of the intestinal microflora and preventing a number of pathological conditions of the gastrointestinal tract. intestinal in children from the first days of life.

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