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Clinical Study
The Effect of Probiotics on Childhood Constipation:
A Randomized Controlled Double Blind Clinical Trial
M. Sadeghzadeh,1 A. Rabieefar,2 P. Khoshnevisasl,3 N. Mousavinasab,4 and K. Eftekhari5
1
Department of Pediatrics, Zanjan Metabolic Disease Research Center, Zanjan University of Medical Sciences, Zanjan, Iran
Zanjan University of Medical Sciences, Zanjan, Iran
3
Department of Pediatrics, Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran
4
Department of Epidemiology, Zanjan University of Medical Sciences, Zanjan, Iran
5
Department of Pediatrics, Zanjan University of Medical Sciences, Zanjan, Iran
2
1. Introduction
Constipation is a common disorder in children and could
have a destructive effect on the physical as well as psychological aspects of health [1]. Its prevalence varies from 0.07%
to 29.6% in different studies [2]. Organic causes cannot be
found in more than 90% of cases [3]. Constipation is defined
as the painful passage of stool less than twice a week or less
than once every three days [4]. Usual treatments including
toilet training, family education, dietary changes, and the use
of laxatives, although useful, are not completely satisfactory
[1, 5]. Therefore, there is a growing interest to find a new
solution [3].
Currently, probiotics were used as an adjunctive treatment for a lot of childhood diseases. The role of probiotics
in gastrointestinal diseases as well as allergic disorders, atopic
Variables
Gender
Male
Female
Mean age (year)
Intervention group
Control group
Total
value
14 (58.3%)
10 (41.7%)
6.1 2.4
10 (41.7%)
14 (58.3%)
6.3 1.9
24 (50%)
24 (50%)
( = 0.248)
( = 0.739)
3. Results
A total of 56 patients were enrolled in the study. Four
patients in the intervention group (three in the first week and
one in the fourth week) refused to complete the study and
were excluded. Four patients in the control group had not
completed the study as well (two did not refer for followup and two patients did not fulfill criteria Rome III during
the study), and were excluded. At the end, two groups of 24
patients were studied.
In the intervention group, 14 males (58.3%) and 10 females
(41.7%) completed the study. The control group consisted of
10 males (41.7%) with 14 females (58.3%). The difference of the
two groups was not statistically significant ( = 0.248). The
mean age of patients in treatment group was 6.1 2.4 and in
control group was 6.31.9( = 0.739). The demographic data
are shown in Table 1.
In the intervention group, 54.2% and in controls 37.5%
had fecal incontinence before the intervention ( = 0.247). In
the first group, 66.7% had abdominal pain in the beginning
of the study compared to 58.3% in the second group ( =
0.551). These patients were followed for improvement of
their symptoms till 4th week.
As shown in Table 2, at the end of the fourth week, the frequency and consistency of defecation improved significantly
( = 0.042, = 0.049, resp.).
At the end of the first week, fecal incontinence and
abdominal pain improved significantly in intervention group
( = 0.030, = 0.017, resp.) but, at the end of the fourth
week, this difference was not significant ( = 0.125, =
0.161, resp.) (Table 3).
Surprisingly, we found that, at the end of the first week,
probiotics had significantly improved weight gain (more than
10%) ( = 0.002), and this difference, although, continued
but was not significant at the end of the fourth week ( =
0.098).
No side effects were noted during the treatment.
4. Discussion
It seems that probiotics which are live microbial ingredients competitively exclude pathogenic bacteria and improve
gastrointestinal upsets. By producingshort-chain fatty acids,
lactic acid, and acetic acid, they reduce colonic PH, change
Table 2: Comparison of symptoms between the beginning and end of the 1st and 4th weeks.
Stool frequency
Stool consistency
Variables
Beginning to 1st week
Beginning to 4th week
1st to 4th week
Beginning to 1st week
Beginning to 4th week
1st to 4th week
value
0.042
0.049
value
0.030
0.017
0.002
the disease, a better effect of this drug in short term, and the
tolerance to treatment.
Conversely, there are some studies which are not similar
to our findings:
Vandenplas et al. stated that probiotics had limited role in
controlling the constipation, although its role in antibioticassociated diarrhea and acute gastroenteritis was confirmed
[6].
Banaszkiewicz and Szajewska had studied eightyfour constipated children (216 years of age) receiving
1 mL/kg/day of 70% lactulose plus 109 colony-forming units
(CFU) of Lactobacillus GG (LGG) orally twice daily for 12
weeks comparing with a control group and concluded that
LGG was not an effective adjunct to lactulose in children
with constipation [17]. We have used lactulose in our patients
too, because it was well tolerated and easily accessible and
different results may be due to the composition of probiotics
used.
Mazlyn and coworkers demonstrated that adults with
functional constipation did not have significant alleviation
in constipation severity or stool frequency, consistency, and
quantity comparing to controls after 4 weeks of treatment
with probiotics [18].
The study of Tabbers et al. on 159 constipated children
receiving fermented dairy product containing Bifidobacterium lactis strain showed that, in spite of improvement in
stool frequency comparing to baseline, the result was not
comparable to controls [19].
Considering these controversies, it seems that larger
studies are needed to clarify the effect of probiotics in constipation. It is recommended to control strictly the regimens
used in both groups, and it seems that a mixture of pre- and
probiotics containing all useful flora would be promising.
Also, we found a significant increase in body weight
which was not mentioned in other studies and it may be due
to improved appetite after decreasing intestinal transit time.
Further investigations are needed to prove this effect.
References
5. Conclusion
[10] Y. Vandenplas, G. Veereman-Wauters, E. de Greef et al., Probiotics and prebiotics in prevention and treatment of diseases
in infants and children, Jornal de Pediatria, vol. 87, no. 4, pp.
292300, 2011.
This investigation revealed significantly increased bowel frequency and improved stool consistency with the combination
of lactulose and probiotics. In our study, the decrease in
episodes of fecal incontinence and abdominal pain was
significant compared to control group at the end of the first
week that may be due to a better effect of this drug in short
term.
Conflict of Interests
There is no conflict of interests.
Acknowledgments
This project was a thesis for a pediatric specialty degree
and was founded by the Research Department of Zanjan
University of Medical Sciences. The authors greatly appreciate
all participants in this study. They also appreciate the helpful
comments of Dr. Akefeh Ahmadiafshar in editing this paper.
[8] G. Alvarez-Calatayud,
J. Perez-Moreno, M. Toln, and C.
Sanchez, Clinical applications of the use of probiotics in
pediatrics, Nutricion Hospitalaria, vol. 28, no. 3, pp. 564574,
2013.
[9] H. Szajewska, M. Setty, J. Mrukowicz, and S. Guandalini, Probiotics in gastrointestinal diseases in children: hard and not-sohard evidence of efficacy, Journal of Pediatric Gastroenterology
& Nutrition, vol. 42, no. 5, pp. 454475, 2006.
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