Cafer Lactulose Trial Report (Department of Gastroenterology)

REPORT

about the clinical trial of kefir enriched with lactulose "Lactusan"

From 05/30/2001 to 06/29/2001, at the Department of Gastroenterology of the Educational and Scientific Center of the Medical Center of the Administration of the President of the Russian Federation, clinical trials of kefir enriched with lactulose "Laktusan" were carried out, produced according to the documentation developed by the All-Russian Research Institute of the Dairy Industry (VNIMI) (OST 49 29-84 "Kefir", change No. 7 to OST 49 29-84 "Kefir with lactulose"). Lactulose "Lactusan" is produced by Felicata Holding, Russia.

The aim of the study was: to evaluate the clinical efficacy of kefir containing lactulose (400 ml of kefir contains 2 g of lactulose "Laktusan") 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 patients under study.

We observed 15 patients aged 17 to 59 years. Men - 3 people, women - 12. Nosologically sick 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 Art. remissions. Colon dyskinesia, predominantly of the hypomotor type (constipation) - 2;

chronic non-calculous cholecystitis without exacerbation. Biliary dyskinesia, predominantly of the hypomotor type - 6.

Patients complained of abdominal pain of varying intensity and localization, a change in the nature of the stool and its consistency (decrease in the 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 evaluating the effectiveness and tolerability of Kefir with Lactulose were:

dynamics of clinical symptoms,

sowing feces for dysbacteriosis before and after treatment,

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

transit time through the intestines of activated charcoal - "carbolene test". Normal 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, the presence of opportunistic flora: fungi of the genus Candida, Klebsiella, Enterobacter, hemolyzing enterococci, Staphylococcus aureus, etc. (see Table No. 1 ).

Against the background of a 15-day course of taking Kefir with Lactulose, positive changes in clinical symptoms were noted: the pain symptom was stopped in 5 people (33.3%) (initially observed in 60%), rumbling in 6 people (initially observed in 6 people (40%)) , a feeling of "transfusion" in 1 person (initially in 1), flatulence in 9 (60%) people (initially - in 13 people (86.6%)). After taking Kefir with Lactulose, the stool consistency returned to normal: formed and soft stools were noted in 60% patients (initially, 80% stools were hard, fragmented). 53,3% patients noted an increase in the volume of fecal matter. The data are presented in table 2.

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

Changes in the composition of the microflora of the colon were revealed: there was a slight increase in the number of obligate flora (bifidobacteria and lactobacilli), the number of patients with defective and hemolyzing Escherichia coli, aureus and other staphylococci decreased, there was a tendency to reduce the number of opportunistic enterobacteria, clostridia. However, fungi of the genus Candida continued to be detected, hemolyzing Escherichia coli and enterococci. In general, the number of patients with a less pronounced degree of dysbacteriosis increased (Table 3).

The method of gas-liquid chromatographic analysis was used to study short-chain fatty acids (SCFA) in feces before and after taking Kefir with Lactulose: the results of the study are presented in Table 4. From the data presented, it can be seen that the patients were actually divided into two subgroups: 1) patients with pathology of the biliary system, where an increase in the content of both individual acids and their total amount was initially stated, 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, multidirectional changes in the level of SCFA are noted: in the first group, there is a tendency to decrease their level, in the second - to increase, i.e. trend towards normalization.

The study of the relative (frequency) content of SCFA is presented in Table 5. The table shows that in the specific content of acids in the first group of patients initially dominated by propionic acid, isobutyric, butyric, isovaleric, valeric acids with a decrease in the proportion of acetic acid. In the second group, there is an increase in the specific content of propionic, isobutyric, isovaleric and valeric acids with a reduced specific amount of acetic and butyric acids. The above changes indicate an initially disturbed anaerobic-aerobic balance. After treatment, there is an increase in the proportion of acetic acid, a decrease in the proportion of propionic acid in both groups, and multidirectional changes in the share of isobutyric, butyric, isovaleric and valeric acids. An analysis was made of the relative content of three basic acids: acetic, propionic and butyric, and the calculated indicators of anaerobic indices (AI = (C3 concentration + C4 concentration) / C2 concentration), reflecting changes in the redox potential of the environment, before and after taking Kefir with Lactulose ( table 6). The presented data more clearly demonstrate multidirectional changes in the content of acetic, propionic and butyric acids in the studied groups against the background of taking Kefir with Lactulose.

Analysis of anaerobic indices (Table 6) indicates a change in the redox potential of the medium with a tendency to equalize this parameter after treatment.

The results of studying the ratio of the content of individual isoacids (isoSp, isoC4, isoC5) to acids (Sp, C4, C5) in the groups of patients studied while taking Kefir with Lactulose are presented in Table 7. parameters, which indicates a change in the ratio of the number and activity of aerobic and anaerobic microorganisms with the ability to proteolysis.

The results of the study of the total amount of SCFA and their salts - S(R-H+ + R-Na+), the total concentration of free short-chain acids S(R-H+), the total concentration of salts of short-chain acids S(R-H+) (mg/g) and molar the ratios of the amount of free acids and the amount of sodium salts of SCFA - S(R-H +) / S (R-Na +) in a group of patients while taking Kefir with Lactulose are presented in Table 8. The table shows that after taking Kefir with Lactulose, the acid equilibrium, which may indicate the normalization of intraluminal pH.

Kefir with Lactulose was well tolerated. No adverse reactions were noted in any patient. Dynamics from clinical blood and urine tests, biochemical parameters of blood were not noted.

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 decreased in 80% cases.

There was a tendency to normalize the time of transit through the digestive tract.

A slight trend towards positive changes in the composition of the colon 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 due to the normalization of the environment and the restoration of intestinal motility.

Kefir with Lactulose is characterized by good tolerance and no adverse reactions.

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