REPORT on the clinical trial of kefir enriched with lactulose "LACTUSAN"

The purpose of the study: to evaluate the clinical efficacy of kefir containing lactulose (400 ml of kefir contains 2 g of lactulose "Lactusan") in the treatment of chronic diseases of the gastrointestinal tract with dysbacteriosis syndrome; to evaluate the tolerability and safety of "Kefir with lactulose" in the group of studied patients.

15 patients aged 17 to 59 years were observed. Men - 3 people, women - 12. Nosologically, patients were distributed as follows:

irritable bowel syndrome with pain and flatulence - 1;

irritable bowel syndrome with a predominance of constipation - 6;

chronic colitis, post-infectious etiology, in the stage of remission. Dyskinesia of the colon mainly of the hypomotor type (constipation) - 2;

chronic non-calculous cholecystitis without exacerbation. Biliary dyskinesia, mainly hypomotor type – 6.

Patients complained of abdominal pain of varying intensity and localization, changes in the nature of stools and their consistency (decreased frequency of defecation to 1 time in 4-5 days, taking laxatives), bloating, rumbling and flatulence.

Kefir with lactulose was prescribed 200 ml 2 times a day (morning-evening) for 15 days.

The criteria for assessing the effectiveness and tolerability of Kefir with Lactulose were:

dynamics of clinical symptoms,

stool culture for dysbacteriosis before and after treatment,

determination of metabolites of saccharolytic flora (short-chain fatty acids of SCFA) in feces before and after treatment,

intestinal transit time of activated charcoal – “carbolen test”. Normally, the transit time is 24-48 hours,

complete blood count, urine, biochemical blood test (total protein, cholesterol, ALT, AST, glucose).

Almost all patients (100%) initially had intestinal dysbacteriosis with a deficiency of obligate flora, a change in the composition of the accompanying flora, and the presence of opportunistic flora: fungi of the genus Candida, Klebsiella, Enterobacteriaceae, hemolyzing enterococci, and Staphylococcus aureus.

Against the background of a 15-day course of taking Kefir with Lactulose, positive changes in clinical symptoms were noted: pain was relieved in 5 people (33.3%) (at baseline it was observed in 60%), rumbling in 6 people (at baseline it was observed in 6 people) %), a feeling of "overflow" in 1 person (at baseline in 1), flatulence in 9 (60%) people (at baseline - in 13 people (86.6%)). After taking Kefir with Lactulose, the consistency of stools normalized: formed and soft stools were noted by 60% of patients (at baseline in 80% the stool was hard, fragmented). 53.3% of patients noted an increase in the volume of fecal masses.

The transit time of carbolene through the digestive tract decreased: before treatment, the carbolene sample was 59.7 hours, after the end of treatment - 35 hours.

Changes were found in the composition of the colon microflora: a slight increase in the number of obligate flora (bifido- and lactobacteria) was noted, the number of patients with incomplete and hemolyzing Escherichia coli, aureus and other staphylococci decreased, and there was a tendency to reduce the number of opportunistic enterobacteria. However, fungi of the genus Candida, hemolyzing Escherichia coli and enterococci, continued to be detected. In general, the number of patients with a less pronounced degree of dysbacteriosis increased.

Patients were actually divided into two subgroups: 1) patients with biliary tract pathology, where an increase in the content of both individual acids and their total amount was initially noted; 2) patients with chronic intestinal pathology, where a decrease in the content of both individual acids and their total amount was initially observed. After taking Kefir with Lactulose, different changes in the level of SCFA are noted: in the first group, a tendency towards their level is observed, in the second - towards an increase, i.e. a tendency towards normalization.

The study of the relative (frequency) content of CFA is presented in Table 5. The table shows that the specific content of acids in the first group of patients is initially dominated by propionic acid, isobutyric, butyric, isovaleric, valeric acids with a decrease in the proportion of acetic acid. content of propionic, isobutyric, isovaleric and valeric acids with a decrease in the specific amount of acetic and butyric acids. valeric acids. An analysis of the relative content of three basic acids: acetic, propionic and butyric, and the calculated indicators of anaerobic indices (AI = (concentration of S3 + concentration of C4) / concentration of C2), reflecting changes in the redox potential of the environment, before and after taking Kefir with Lactulose. Multidirectional changes in the content of acetic, propionic and butyric acids in the groups studied against the background of taking Kefir with Lactulose.

Anaerobic index analysis indicates a change in the redox potential of the environment with a tendency to equalize this parameter after treatment.

Patients of the studied groups have a multidirectional change in the content of the above parameters, which indicates a change in the ratio of the number and activity of aerobic and anaerobic microorganisms that have the ability to proteolysis.

After taking Kefir with Lactulose, the acid balance is normalized, which may indicate the normalization of intraluminal pH.

Kefir with lactulose was well tolerated. No adverse reactions were noted in any patient. No changes were noted in clinical blood and urine tests, or in biochemical blood parameters.

CONCLUSION:

Kefir with Lactulose is an effective dairy product for the treatment and prevention of chronic pathology of the gastrointestinal tract, accompanied by dysbacteriosis syndrome. Clinical symptoms after 15 days of taking Kefir with Lactulose were stopped or significantly reduced in 80% of cases.

A tendency to normalize the transit time through the digestive tract was noted.

A slight tendency to positive changes in the composition of the colonic ecosystem was revealed according to the microbiological study of feces.

There is a change in the metabolic activity of the colonic microflora and the generic composition of the microflora. There is a tendency to normalize anaerobic-aerobic relationships, there is a change in the intracavitary redox potential towards normal values and acid balance, which is probably largely associated with the normalization of the environment and the restoration of intestinal motility.

Kefir with lactulose is characterized by good tolerability and the absence of adverse reactions.

These data allow us to recommend the use of Kefir with Lactulose in the treatment of gastrointestinal diseases accompanied by impaired motility and microbial spectrum.