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The effect of Lactusan on bowel function

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PURPOSE OF THE STUDY
Determine the presence or absence of therapeutic and prophylactic properties of dairy products enriched with lactulose, produced according to the technical documentation developed in VNIMI.

OBJECT OF STUDY
Kefir with the addition of lactulose "Lactusan" (OST 49 29-84 "Kefir", change No. 7) was chosen as the object of research. At the same time, the researchers proceeded from the assumption that the results of the study of this object can be transferred to other dairy products enriched with lactulose.
It is well known that kefir itself is a means of improving bowel function. Therefore, in order to determine the effectiveness of kefir enriched with lactulose (OST 49 29-84 "Kefir", change No. 7 to OST 49 29-84 "Kefir with lactulose), it was necessary to compare it with the action of ordinary kefir produced by traditional technology.
Kefir enriched with lactulose was prepared at VNIMI according to the following technology: first, kefir was prepared according to traditional technology, then lactulose syrup "Lactusan" was added. The homogeneous mixture was poured into molds with a capacity of 200 ml and hermetically sealed with aluminum foil. Control samples were prepared in the same way, but without the addition of lactulose.

RESEARCH METHOD
The tests were carried out with two groups of children, one of which is considered as a control group (receiving kefir without additives), and the other as an experimental group (receiving kefir with the addition of 0.5% lactulose syrup "Lactusan").
For the study, children aged 1 to 15 years were selected, mainly with impaired bowel function, expressed in the form of constipation or irregular stools with mucus, with pain in the abdomen. In some cases, children also had diseases such as atopic dermatitis, infectious diseases and others. The treatment was carried out on an outpatient basis, but the patients were under constant supervision of the doctors of the Morozov hospital. Each child received one packet of product per day. Thus, the daily dose was 200 g, and the study course lasted 20 days. Before and after the course, a bacteriological analysis of feces was performed.

RESULTS OF THE STUDY
This report presents data from the results of a study of 30 children who, in addition to clinical observation, have analysis data for dysbacteriosis before and after admission:
  • control group (kefir without lactulose) - 10 children,
  • experimental (kefir with lactulose) - 20 children.

To evaluate the results, we used clinical data obtained by direct observation of patients by a doctor, as well as by interviewing parents of sick children, and bacteriological analysis data.

Bacteriological analysis was carried out in the laboratory of the Morozov hospital according to the method adopted in Russia. The results are given in the Appendices: tables No. 1 - control group, No. 2 - experimental group and No. 3 - comparison.
In the control group, an increase in the level of bifidobacteria was only in 20 % children, in the experimental group, who took kefir with lactulose, in 47 %. In the change in the level of lactobacilli, the difference is even greater - 20 % versus 65 %, respectively. Ordinary kefir caused a decrease in lactobacilli in 50 % children, while kefir with lactulose - only in 1 person (5 %). At the same time, the stool in the experimental group returned to normal in all (100 %) children.

General conclusion on clinical studies of kefir with lactulose produced according to OST 49 29-84, change No. 7:
    1. Kefir with lactulose, unlike ordinary kefir, has pronounced bifidogenic properties, that is, it significantly increases the number of bifidobacteria in the microbial pool of the large intestine.
    1. Kefir with lactulose very markedly increased the level of lactobacilli, which was not observed in the group taking regular kefir.
    1. When taking kefir with lactulose, suppression of pathogenic and conditionally pathogenic microflora is observed.
    1. Kefir with lactulose has a positive effect on intestinal function, eliminates constipation and other intestinal disorders in children.
  1. The use of kefir with lactulose improves the clinical picture: reduces the manifestations of atopic dermatitis, improves appetite, improves the condition after an intestinal infection, improves the general condition of the body and intestinal function after antibiotic therapy.


CONCLUSIONS:

Kefir, enriched with lactulose "Laktusan" according to OST 49 29-84, change No. 7, has a more favorable effect on the intestinal microflora than ordinary kefir.

We recommend kefir with lactulose (OST 49 29-84, change No. 7) as a mass product for the prevention of diseases of the gastrointestinal tract, including dysbacteriosis and intestinal dysfunction.From the Department of Children's Diseases of the Peoples' Friendship University of Russia (Department 24 of the Morozov Children's City Clinical Hospital):

head of department,
Doctor of Medical Sciences,
Professor		 L. T. Kuzmenko
 assistant,
Candidate of Medical Sciences		 N.I. Petruk

From the Department of Urology and Operative Nephrology of the Peoples' Friendship University of Russia (Clinical Hospital 64 in Moscow):

head of department,
Doctor of Medical Sciences,
professor, academician of the Academy of Sciences of Ukraine		 V. E. Rodoman
Chief Researcher,
Doctor of Biological Sciences		  IN AND. Maksimov


I certify the signatures of employees of the Peoples' Friendship University of Russia.

Scientific Secretary of the Academic Council
candidate of chemical sciences, professor		   A.P. Krapivko

APPS
Explanations for tables.
According to the Russian standard, the following indicators are the norm for children over 1 year old (the abbreviations used in the table are entered in brackets):
  • bifidobacteria (B) - 108 or more,
  • lactobacilli (L) - 106-108,
  • Escherichia (ESh) - 107-108, of which lactose-negative (LNESH) - 10%,
  • hemolytic (HESH) - 2%,
  • enterococci (EN) - 105-106,
  • Klebsiela (Cl) - <104,
  • staphylococci (ST) - <104,
  • yeast-like fungi (DG) - <103.

Only those data are entered into the table that differ from the given values, or show dynamics.

The chair is characterized by the following terms:
  • "norm" - regular stool, normal consistency,
  • "Sheep feces" - a manifestation of constipation.

To characterize the microflora of feces, measurements were carried out according to 12 of the above indicators. The tables contain data on those indicators that go beyond the above norms or that undergo changes due to the intake of kefir. Those indicators of bakanaliza, which fit into the norm, are not included in the table. The designation “ots (3)” is used when there is no culture of microbes at dilutions for lg KOE = 3.

In the control group of 10 children, 7 (70 %) had impaired bowel function in the form of constipation. One of them has a stool with mucus.
After a course of kefir (without lactulose), the stool returned to normal in 5 children and partially in 2 children. Stool bacterial analyzes showed reduced levels of bifidobacteria (up to log COE = 7) and lactobacilli (up to 5-6) in four children. After taking kefir, the level of bifidobacteria increased in two children. The level of lactobacilli increased in two, but dropped sharply in four children. Other changes in the composition of the microflora in the control group were rare and insignificant.

Table #1

Deviations from the norm or changes in the microflora and the shape of the stool
in children who took ordinary kefir (control group).
Dose 200 g per day, course 20 days.
No. Name and age of the child  Microflora bakanal data,
lg KOE, %		 Chair feature  Notes
 Before taking kefir  After taking  Before taking kefir  After taking
1 MM.,

2 years

  L  8 ots (6)  norm  norm
2  M.A.,
3.7 years		 B
L
ES
EN		 7
6
8
8		 9
7
8
8		  constipation, stool with mucus  norm  Poor appetite persisted
3  K.N.,
4 years		 B
L
ES
Art.
golden		 7
6
6
4		 8
6
7
ots (3)		 constipation stool every other day Recurrent bronchitis
4  Z.K.,
5 years		 B
L
E
W		 7
5
5		 7
<5
6		 constipation stool every other day Moderate manifestation of dermatitis remained
5  M.A.,
6 years		 L
ES
LNESH
staph		 8
54		 ots (3)
3
83%
4		 "sheep feces" norm
6  N.J.,
7 years		 L
ES		 8
5		 ots (6) norm norm
7  K.N.,
7 years		 L 8 ots (6) "sheep feces" every other day norm
8 B.N.,
8 years		 L 7 7 constipation norm Bronchial asthma
9 R.A.,
10 years		 B
L		 7
<6		 8
<6		 constipation norm Persistent toxicoplasma infection
10  K.O.,
11 years		 EN 7 norm norm

In the second group, where kefir was taken with a 0.5% lactulose supplement "Lactusan", 20 children from 1 to 12 years old. In 9 children (47 %) in the experimental group, the level of bifidoflora after the course of kefir with lactulose "Lactusan" increased, but in three children (15 %), who suffered viral and other diseases during the intake, it decreased by 1 log unit. An increase in the level of lactobacilli was observed in 13 children (65 %), and in three (15 %) a slight decrease was observed. Against the background of taking kefir with lactulose, there was a noticeable cleansing of the intestines from opportunistic flora (hemolytic, low-fermenting and other forms, as well as Proteus, Klebsiella, staphylococci and others).

Table number 2

Deviations from the norm or changes in the microflora and the shape of the stool
in children taking kefir with 0.5% lactulose supplement
"Laktusan" (experimental group). Dose 200 g per day, course 20 days
No. Name and age of the child  Microflora bakanal data,
lg KOE, %		 Chair feature  Notes
 Before taking kefir  After taking  Before taking kefir  After taking
1 M.I.,
11 months		 B
L
cl
Citrobacter
Art. golden
Art. hemolith.		  6
<6
<6		 8
6
ots (5)
5
4
100%		 Stool with mucus and undigested lumps  norm Reception on the background of SARS.
Appetite improvement
2 HELL..,
1 year		 L
cl
EN		 <6
5
7		 8
ots (5)
4		 The chair is liquid, 3-4 times a day with undigested lumps norm Reception on the background of SARS.
Appetite improvement
3 G.V.,
1 year		 B
L
EN
PC
cl		 5
ots(6)
6
<3
6		 6
6
9
ots (3)
ots (3)		 Mushy with mucus and undigested lumps, tendency to constipation norm Atopic dermatitis. Previously, before taking kefir with lactulose, he was treated with phage for dysbacteriosis
4 F.K.,
1 year 10 months		 B
L
cl
AP		 8
6
4
5		 9
7
ots(4)
ots(4)		 Mushy with mucus and undigested lumps, tendency to constipation norm Decreased symptoms of atopic dermatitis
5 A.R.,
2 years		 L
ES		 5
6		 7
7		 mushy, green norm Bronchial asthma
6  F.P.,
3 years		 norm norm Constipation, stool with mucus norm Decreased manifestation of atopic dermatitis
7 B.A,
3 years		 B
L
ES
GESH
Proteus		 9
7
<6
7
6		 8
8
8
4
ots(3)		 Dysbacteriosis for a long time norm Decreased manifestation of atopic dermatitis
8 M.E,
3 years
5 months		 B
L
St. Epidermis		 9
7
7		 9
8
ots (3)		 constipation norm Reception in two stages: kefir without lactulose - there was constipation, then switching to taking kefir with lactulose - the stool returned to normal
9 A.A.,
4 years		 L
ES
GESH
ST		 8
5
No
4		 ots (6 )
8
100%
ots (4)		 Unstable norm Presumably food poisoning at the end of the course
10 S.V.,
4 years		 L
LNESH
EN
P		 ots (6)
No
7
8		 ots (6)
5%
7
8		 Intestinal colic, tendency to constipation norm Appetite improvement
11 B.S.,
6 years		 AP 4 ots (3) Constipation, abdominal pain  norm Had an intestinal infection and recovered in 1 day
12 P.D.,
6 years		 EN
P
DG		 6
ots (3)
3		 7
8
ots (3)		  "sheep feces"  norm He had been ill with bronchitis at the end of treatment, received antibiotic therapy
13 K.K.,
6 years		 B
L
ES		 8
6
10		 9
8
10		 constipation norm Dysbacteriosis from birth, decreased manifestation of atopic dermatitis
14  G.O.,
7 years		 B
L
ES		 8
7
8		 7
6
7		 constipation norm Bronchial asthma, had a viral disease before the second bacanalysis
15 K.K.,
7 years		 L 5 <6 norm norm Reception in two stages: kefir without lactulose gave the elimination of constipation, taking kefir with lactulose led to an increase in the level of lactobacilli
16 K.K.,
7 years		 B
L
ES		 8
7
8		 9
8
5		 "sheep feces" norm
17  Ch.M.,
7 years		 B
L
EN		 ots (7)
ots (6)
7		 9
8
ots (6)		 "sheep feces" norm
18 I.A.,
8 years		 B
L		 6
6		 7
8		 constipation norm Chronic pyelonephritis. Appetite improvement
19 V.T.,
9 years		 B
L
ES		 8
8
8		 9
6
7		 constipation in one day Recurrent obstructive bronchitis
20 K.D.,
12 years		 B
L
ES
Art. solotis.		 7
6
6
4		 9
7
8
ots (3)		 constipation norm Rheumatoid arthritis

GV, 1 year old, had dysbacteriosis of the 2nd degree and at low levels of lacto- and bifidobacteria, had a markedly high level of Klebsiella (lg COE = 6). This child was treated with phage, but there was no improvement. The course of treatment with kefir with "Lactusan" led to the disappearance of Klebsiella and an increase in the number of bifido- and lactoflora.

Significant improvements were observed in the clinic, when the disturbances in the intestinal function disappeared and the stool returned to normal. In two other cases, when children before treatment had a reduced level of bifido- and lactoflora (K.K., 7 years old and Ch.M., 7 years old), complete normalization of the microflora was achieved, and the tendency to constipation disappeared and the stool returned to normal.

In some cases, the effect of kefir turned out to be insufficient and an additional course of kefir with lactulose "Lactusan" was required.

In the child K.K., 7 years old, kefir contributed to the elimination of constipation, however, its effect on the composition of the microflora was not sufficiently effective, because. lactobacilli remained at a very low level. After a course of kefir with lactulose, the level of lactoflora increased from < 5 to 6.

In another child (M.E., 3.5 years old), a course of kefir led to constipation, and this child was transferred to the experimental group receiving kefir with lactulose "Lactusan". Achieved normalization of stool and improvement of microflora composition.

Three children had atopic dermatitis. After a course of kefir with lactulose, its manifestations decreased sharply. In one child (P.D., 6 years old), after a course of kefir with "Lactusan", there was an increase in the level of proteus (up to lg KOE = 8), which is explained by the postponement of bronchitis at the end of treatment and antibiotic treatment.
Similarly, in a child (A.A., 4 years old) due to food poisoning at the end of the course, the level of Escherichia increased (up to lg COE = 8) by 100% due to hemolytic forms. However, in all these cases, the general condition of the child improved, the stool returned to normal, and the main indicators of bacillary tests were at the level of normal values.
The beneficial effect of kefir with lactulose "Lactusan" in comparison with kefir without additives can be judged by the content of bifidus and lactobacilli in feces (Table 3).

For a complete correctness of the comparison of the action of kefir made according to traditional technology, and kefir enriched with lactulose, other equal conditions should be observed. For a correct comparison, the statistics did not take into account the data of the bacteriological examination of children who had diseases (ARVI, food poisoning, and others) while taking the products whose effect is being studied, because. it was the past diseases that could make unfavorable adjustments to the composition of the microflora.

Table 3 compares the data of children, all other things being equal.

Table number 3.

Comparison of changes in the level of bifido- and lactobacilli in children,
treated with regular kefir (control group) and kefir,
enriched with lactulose "Lactusan" (experimental group)
group of children bifidobacteria lactobacilli
promotion downgrade promotion downgrade
Control
(kefir), 10 people		 20 % 0 20 % 50 %
Experienced
(kefir with lactulose "Laktusan"),
19 people		 47 % 5 % 65 % 5 %

If in the control group an increase in the level of bifidobacteria was only in 20 % children, then in the experimental group, who took kefir with lactulose, it was in 47 %. In the change in the level of lactobacilli, the difference is even greater - 20 % versus 65 %, respectively. Ordinary kefir caused a decrease in lactobacilli in 50 % children, which sometimes exceeded 100-fold, while kefir with lactulose - only in 1 person (5 %). At the same time, the stool in the experimental group returned to normal in all (100 %) children.

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