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EFFECT OF DOMESTIC MULTI PROBIOTIC ON ACUTE RESPIRATORY DISEASE MORBIDITY RATES AND PSYCHOMOTOR DEVELOPMENT INDEX IN ORPHANS FROM CHILDREN'S HOME

S.A. Kramarev, O.V. Vygovskaya, V.V. Berezhnoy, R.A. Moiseenko, A.P. Moshchich, S.V. Ursulenko, D.S. Yankovskiy
A.A. Bogomolets National Medical University, Kyiv P.L. Shupik National Medical Academy of Postgraduate Education, Kyiv Zhytomyr Regional Children's Home Prolisok O.D. Company


The article presents results of a study on the effect of domestic multi probiotic Symbiter onto acute respiratory morbidity index and psychomotor and physical development indicators of children orphans from the children's home. 79 children aged between three months and three years and eight months participated in the study. The inclusion of Symbiter multi probiotic into the ARD prevention programme contributes to a twofold decrease of ARD morbidity and reduces both the incidence of complications and frequency of antibiotics administration for their therapy. The preventive effect of Symbiter multi probiotic continues for six months after intake discontinuation. Administration of Symbiter multi probiotic enhances children's physical development and body mass increase and has positive effect on their psychomotor development.
Keywords: children, probiotics, Symbiter, acute respiratory infections, quotient, morbidity, psychomotor development, physical development.



Introduction

Ukraine is second only to Russia in Europe in the number of orphan children. According to official statistical data, the number little orphans currently living in Ukraine has reached 103 thousand and grew by 7% in 2011 only [1, 12]. The independent experts think the minimum figure is about 115–120 thousand orphans; add here those unaccounted for and the number can grow to even about 150–160 thousand children left without parental care [8].

Children that grow out of family show poorer health indicators — general and infection-induced morbidity, physical, psychic, psychomotor and social development — than their peers. The health status of these children is formed by specifics of the living in a locked group, availability of unfavourable pre-morbidity background, burdened anamnesis and many other reasons [1, 5, 11].

Respiratory diseases, alimentation and metabolism disorders, reduction of immunity are 1.5–2 times more likely to be found in children's home residents than in their peers with full families [12]. More than a half of these children show plastic process disturbances like body mass and growth deficit or deviations of physical development (low heath, body mass deficit) [5,10].

Mass and body length (height) indicators of children's home fosterlings are lower than those of children growing in families — even in spite the lack of verifiable differences in such indicators at birth [10, 12].

Acute respiratory infections (ARI) are among the most frequent causes of high morbidity in organized children groups. Children in any age (particularly infants) who live in organised children groups (children's houses, boarding schools) are more prone to high risk of ARD development. At the time of flu epidemic up to 90% children group members catch the disease. Children in organised children groups are also susceptive to repeat respiratory diseases. More than 60% children admitted for the first time to organized children groups fall within the group of sickly children [4, 14].

Efficacy of probiotics in ARD prevention in children and adults has been confirmed by a number of clinical trials [17, 18].

With a view of the above, the objective of the current trial was to investigate ARD morbidity indicators in children residing in children's home environment and their psychomotor and physical development at in conditions of preventive administration of Symbiter Acidophilous multi probiotic product.

Trial objective: research into the effect of Symbiter Acydophylous multi probiotic on ARD morbidity indicators and psychomotor and physical development indicators of children staying in closed children care institution (the children's home).

Trial design: open prospective randomised controlled comparative study in parallel groups.


Research Material and Methods

The children in the trial were randomised into groups. The trial protocol was approved by the Ethics Commission of A. A. Bogomolets National Medical University (Kyiv, Ukraine). Custodians of the trial participants signed their informed consent before the start of the trial.

The subject matter of the study: 79 children aged between three months and three years and eight months were involved in the trial. The average age of the children was 1.9±0.12 years and the median, 2.05 years. 40 (50.6%) were boys and 39 (49.4%), girls.

Subject matter of the trial: Symbiter Acidophilous multi probiotic is a symbiotic association of 14 strains of bacteria: Bifidobacterium (B. bifidum, B. longum); Lactobacilli (L. acidophilus, L. helveticus, L. delbrueckii, L. bulgaricus, L. bulgaricus, L. lactis); propionate-oxidising bacteria (P. freudenreichii, P. shermanii, P. acidopropionici); Lactococci (Str. silivarius, Str. tervophilus)and acetic acid bacteria (Acetonobacter aceti) [16].

Probiotic: active substance: a biomass of live cells of the symbiosis of Bifidobacterium, Lactobacilli, Lactococci, propionate-oxidising and acetic acid bacteria, CFU/cm3, at least: Lactobacilli and Lactococci: 1.0х109; Bifidobacterium: 1.0х108; propionate-oxidising bacteria: 3.0х107; acetic acid bacteria: 1.0х105.

Additives: skimmed fermented milk [16]. The trial procedure: the trial was organised into two phases with total duration of nine months. The first phase involved three-month-long observation of the children during the ARD morbidity increase period (November till February). The children were randomised into two groups with 41 children in the main group who received, besides non-specific ARD prevention, also Symbiter Acidophilous multi probiotic one dose q. d. and 38 children in the control group who were administered only non-specific ARD prevention measures.

At randomisation, the groups showed no meaningful difference by age, sex, pre-morbidity background, stay conditions or general development quotient (GDQ
(Table 1).



The second phase included the following six months of observation (February — July) within which followup of the children along the established observation parameters was carried out.

The parameters registered during the trial comprised medical examination of each participating child with determination of physical development indicators like weight, height, head circumference at the beginning stage and then monthly for the duration of the trial.

At the beginning of the 1st phase and at the end of the 2nd phase all the children had their psychomotor development indicators verified using the Vasylko-Manov-Tomov technique. The psychomotor development (PMD) was evaluated by determining the general development quotient (GDQ) [7]. Pursuant to the technique, normal psychomotor development correspondent to GDQ score 100 points and higher while mild GDQ retardation was within the range of 90 to 99 points, moderate GDQ retardation was within the range of 80 to 89 points, and the range not exceeding 79 points was deemed as the pronounced level of GDQ retardation [7].

Physicians in the research group filled out their daily questionnaires in which they noted values of the research parameters.

Statistical analysis: for the purposes of comparison of final measurements, one-way ANOVA test and method for assessment of differences between frequencies of characteristic occurrence in various observation series were applied. Mean values and standard deviations (М±m) were determined. Differences were deemed statistically significant if at р<0.05. For the purpose of psychomotor development index assessment, mean values, the median value and interquartile range (in percentiles) were studied. For confidence estimation of differences, the Fisher criterion and the Pearson criterion were used [2]. The statistical analysis was carried out in MS Excel 2007.


Trial Results and Their Discussion

During the first trial phase, ARD prevalence in children from the main group was two times less frequent
(p<0.01) than in the control group (Pic. 1).



Children in the main group also had two times lesser number of ARD (р<0.001) per one child (Pic. 2).



The main group also showed a trend towards reduction of prevalence of bacteria-induced ARD complications: e.g., complications in the form of acute catarrhal otitis media were found in just one patient as opposed to seven children in the control group (p>0.05) (Pic. 3).



While complications development in the main group of children required no antibacterial medications, these were necessary in the control group (Pic. 3). In the following six months of observation that ensued the first phase of the trial the number of children who contracted ARD in the main group was two times less than that in the control group (Pic. 4); moreover, the number of per-child ARD cases in the main group was two times less too (р<0.05).



ARD complications were registered in just one child from the main group vs. seven in the control group (р>0.05) (Pic. 5). Antibacterial medications were administered to only one child in the main group and eight in the control group (p<0.05) (Pic. 5).



In the group of children who were administered Symbiter multi probiotic for three months, the average weight gain per child for the period made 903±67 g vs. 814±92 g in the control group (Pic. 6). After nine months into the trial, the average weight gain in children from the main group made 1,623±107 g per child versus 1,220±119 g (p<0.02) in the control group (Pic. 6).



During the studying of psychomotor development in children in the first week from the trial start both groups had their GDQ level determined and assessed as the reference base. It scored to 62.2±2.2 in average for children in the main group and 64.9±2.9, for children in the control group (р>0.05). The median reference GDQ in children from the main group scored 61±[54–72]. For control group, the median reference GDQ made 65.5±[51.3–76.5]. According to the data obtained, the majority of main group (85.4%) and control group (78.9%) children showed a pronounced grade of psychomotor development retardation at initial examination. For that period, a moderate grade of psychomotor development retardation was registered in 12.2% children from the main group; 2.4% had a mild expression. For the control group, a moderate grade of psychomotor development retardation was determined in 13.2% children, 5.3% had a mild level and one child was found to have the normal level of psychomotor development. The data in Table 2 show that both groups were representative by their psychomotor development levels and showed no significant differences in their reference GDQ levels.

During the trial, 23 children were excluded from the trial because of transfer to another educational institution or reunification with the family: of these, 13 were from the main group and 10, from the control group.

The 2nd trial aimed at determining psychomotor development of the children was carried out nine months after the beginning of the whole research.

During the research into GDQ dynamics throughout the trial period, the children in the main group showed the average score of 70.9±2.38 (р<0.05) with median at 76±[60–83] (Table 2). During the 2nd trial, the GDQ indicator for these children was found to verifiably increase by 15% compared to the reference indicator (р<0.05). For the children in the control group, the GDQ averaged to 66.90±3.47 (р>0.05) with median at 67±[50–81]. The GDQ indicator's observation dynamics showed an increase by only 7.4% compared with the reference base (р>0.05) (Table 2). In the second trial, the main group showed a mild level of psychomotor development retardation in 14.3%, children, a moderate level, in 35.7% and a pronounced level, in 50% children. The group observation dynamics showed a 35.4% decrease in the number of children with pronounced level of psychomotor development retardation owing to their transfer from that group to those with higher levels of psychic health status (р<0.05) (Table 2).



For the control group, a mild level of psychomotor development retardation was registered during the 2nd trial in 10.7% children, a moderate level, in 17.8% and a pronounced one, in 67.9% children from the group. One child retained its normal development status. A positive dynamics the group demonstrated in its GDQ indicator characterising psychomotor development level was nevertheless not really expressed. The number of children with pronounced level of psychomotor development retardation in the control group reduced just by 11% (р>0.05) (Table 2). During the 2nd trial, the children in the main group showed a 1.2 times increase in GDQ indicator compared to their peer in the control group (р>0.05). The number of children with pronounced level of psychomotor development retardation in the main group decreased by 18% compared with the control group (р>0.05) and the number of children with moderate level of such retardation increased by
18% accordingly (р>0.05) (Table 3).



We also studied dynamics of the general development quotient in children from the main and control groups (Table 3). Positive GDQ dynamics was noted in 85.8% children from the main group with lacking or negative dynamics in only 14.2% them. In the control group, positive GDQ dynamics was registered in 57.1% children with 42.9% showing either negative GDQ dynamics or no dynamics at all. The number of children in the main group with increased GDQ was 1.5 times higher (р<0.05).

In the children from the main group who had positive GDQ dynamics, the GDQ grew by more than 10 points in 41.6% cases; by 5 to 10 points in 29.2% cases and by 0 to 5 points, in 29.2%. As regards the control group, the GDQ grew by 0 to 5 points in 62.5% children, by 5 to 10 points, in 25% and by more than 10 points, in 12.5% children (Table 3). GDQ increase by more than 10 point was 3.3 times more frequent in children from the main group than in their peers in the control group (р<0.05).

Thus, dynamic observation of the children in the main group administered Symbiter multi probiotic allowed outlining a verifiably positive dynamics of GDQ that characterises the level of psychomotor development and the degree of its retardation.

No need for hospital admittance or cases of diarrhoea was registered in either group during the trial. No adverse effects were registered in any of the trial participants administered Symbiter Acydophilous multi probiotic.


Conclusions

The reference health status of children raised in children's houses is insufficient; almost all (98%) of these foster children grow in a 'communication-deficient environment' and hence, in spite of good diet and medical care, are slow in their neuropsychic development.

The absolute majority (74.1%) of them demonstrate a comprehensive retardation of their neuropsychic development [12, 13]. In a greater number of cases this is linked to the effect of a range of pathogenic factors
(infections, intoxications, traumas etc.) on the CNS of the foetus during pregnancy, at delivery and within first years of life [11, 12]. At school age it manifests in cognitive abnormalities, emotional and volitional immaturity, detraction, perception and memory reduction, arrest of verbal and fine motor skills and weakening of voluntary behaviour regulation capabilities [12].

Foster children have verifiably higher ADR prevalence compared to children living in families. In 67% cases they characteristically have the psychomotor development retardation syndrome [12].

Foster children from children's houses also demonstrate considerable deviations in their somatic status which, combined with other factors, lead to an erosion of organism's adaptation capacities and increased morbidity already in the infancy period and from here, to higher ARD prevalence and higher percentage of psychomotor development retardation [1, 5, 12]. ARDs account for more than 90% in the structure of infectious pathologies in children [4, 14]. Foster children in children's houses are two to three times more prone to ARD (from six to eight times a year in the first year to four to six times in the second year to three to four times a year in the third year in average) [12]. Repeated ARDs lead to erosion of immune resistance, overstrain and sometimes, disruption of compensation and adaptation mechanisms, various functional disorders and early onset of chronic pathologies and delays with physical and psychic development [10,11,12].

This trial is the first in Ukraine to study the effect of domestic Symbiter Acydophilous multi probiotic on ARD prevalence levels and physical and psychic development of foster children in children's houses. The trial showed that the administration of the product improves psychomotor and physical development of children and reduces their ARD morbidity levels not only during the intake but also for quite some time after it.

Mechanisms of probiotic micro flora effects on ARD prevention and therapy remain underexplored. Earlier studies have shown an increase of initially reduced levels of T and B lymphocites as well as an increase in interferon production in recurrent and long-time ARD children administered probiotic containing B. bifidum N1 [9]. It has also been shown that administration of a L. acidophilus — containing probiotic to children prone to frequent ARD and with lower interferon production rates contributes to increased general interferon blood levels and enhanced synthesis of certain interleukins like IL_4, IL_10, and TNF [3].

The mechanism of probiotics' effect on physical and psychomotor development is still not known: very few randomised controlled clinical trials to assess efficacy of various probiotic microorganism species and their preventive effect on ARD have been carried out to date.

While in our view the enhancement of physical and psychomotor development in children administered Symbiter Acydophilous is related to a decrease of ARD prevalence in them, the issue still needs to be researched further.


References
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