New Biotechnological Forms of Nutritional Supplements Aimed at Improving the Gut Disbiosis and Their Clinical Appraisal

INTRODUCTION

Normal microbiota consists of a number of microbial communities, which can be characterized by a certain composition of microorganisms. These microorganisms colonize people’s skin and mucous membranes and serve as the first nonspecific barrier, which protects the body from the adverse factors of both the internal and

external environment. The microbiological film that covers the body’s intestinal wall, mucous membranes, and skin consists of 100 milliards of microbial cells. Moreover, the microbiological status of a person is essential for the stable functioning of all organs and systems.

A person’s microbiota is mainly concentrated in the intestine. This fact makes the intestine a very vulnerable organ, suffering the most from the unnatural lifestyle, which may involve psychological and emotional stress, eating disorders, uncontrolled intake of medications, bad habits, etc. The intestine’s normal functioning is crucial for the body. At the same time, the gastrointestinal disease is one of the most common reasons for visiting a doctor. Other diseases such as cardiovascular and autoimmune disorders, skin, liver and kidney diseases, allergies, depression, and others are also associated with the gut functioning and flora state [1-11].

Microbiota serves as a reliable and objective indicator of a person’s health and diet, so it seems essential to restore the disturbed microbiocenosis, employing the nutrition factor [12-20].

MATERIALS AND METHODS

ArtLife Company was involved in developing biologically active compounds and applying innovative biotechnologies:

• nutritional supplement 1 is designed for metabolic detoxication and gut biocenosis improvement. It contains modified sorbents, which can neutralize bacterial endotoxins;
• nutritional supplement 2 is a biotechnological consortium of probiotics and prebiotics. Probiotics are represented by live microencapsulated forms of Bifidobacterium and Lactobacillus bacteria. This compound helps support the immune system and maintain health;
• nutritional supplement 3 is a biotechnological complex of bacterial metabiotics. It selectively absorbs endotoxins and serves as a metabolic and prebiotic means to improve gut biocenosis;
• nutritional supplement 4 is a plant-based biotechnological product aimed at supporting both the balance of the gut-friendly microflora and the body’s defenses. It prevents the growth of yeast fungi and pathogenic bacteria, enhances colonization of the body-friendly bacterial flora, boosts the body’s defenses, and has a pronounced anti-inflammatory effect.

The effectiveness of the developed products was evaluated during the clinical trials involving 10 volunteers (1 male and 9 females aged from 33 to 72. All of them were white-collar workers).

They were motivated by the following factors: health promotion, weight loss, and elimination of disagreeable symptoms of digestive system disorders.

The provoking factors affecting the volunteers’ health included unfavorable dietary patterns, being overweight, and psychological and emotional stress.

The volunteers had several tests taken before and after the treatment to examine their blood biochemical, hematological, and immunological properties. In addition, they underwent fecal sugur and feces occult blood tests. 

After thorough clinical and laboratory studies, the volunteers were diagnosed with fatty liver disease (6 people), obesity (6 people), pancreatitis (4 people), hypothyroidism (4 people), chronic gastritis and duodenal ulcer (8 people), gallstone and acalculous cholecystitis (4 people), irritable bowel syndrome (4 people), and resected stomach (1 person).

RESULTS AND DISCUSSION

All participants demonstrated that gut microbiota disorders ranged from minimal to profound.

All of them completed the questionnaire to evaluate their physical condition on a 10-point scale before and after the program.

All the volunteers took the developed biological compounds following the scheme presented in Table 1.

Table 1. Nutritional supplement intake scheme

Different organs and systems disorders were recorded while evaluating the patients’ physical

 health (Table 2).

Table 2. Subjective evaluation of physical health before and after biologically active compounds intake: questionnaire results

*Note:  0 – no changes; 10 – pronounced changes

As we can see, the nutritional therapy resulted in 60 % - 100 % improvement in the patient’s physical health.

All the volunteers (100 %) showed positive dynamics of cytolysis, cholestasis, and lipid    metabolism (Table 3). 5 tests were taken during the program. Each time the blood sample was taken before and after the administration of the supplement.

Table 3. Changes in blood chemistry results before and after supplements intake

Stool analyses of 6 volunteers (60 %), taken before the treatment, revealed latent disaccharidase deficiency, which had not been diagnosed previously. None of them (0%) had this disorder after the program. 

While studying the gut microbial landscape of all volunteers before the program, we found gut microflora disorders of different extents in 100 % of cases: deficiency of defensive symbionts (Bifidobacterium, Lactobacillus bacteria, Escherichia coli (Lac +) and occurrence of pathogenic microbes (Klebsiella pneumonia, Candida Albicans). Microbiota restoration was recorded in 9 cases (90 %) after the participants finished the 45-day program (Table 4).

Table 4. Changes in the colon microbial landscape

At the beginning of the program, the participants complained of a change in bowel habits from constipation to diarrhea, bloating and flatulence, rumbling, and abdominal pains of various locations and characters. The presence of mucus in stool was recorded in all the tests. 8 participants (80 %) reported no such complaints after the program, while 2 participants (20 %) reported fewer complaints.

All the patients showed positive changes in their coprogram (Table 5).

Table 5. Changes in stool test results