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1 sachet twice
dailv, _ 31O m, tvndallized probiotics per dose) for
five davs in addition to the WH standard treatment.
1he control ,roup received onlv the WH standard
treatment. We confirmed that outpatient subjects
received treatment bv telephonin, their parents. Nurses
confirmed administration of therapv for the inpatient
subjects. lrequencv of diarrhea and the side effects of
the therapv were recorded bv parents or nurses on a
standardized form. 1he outcomes of the studv were
the duration and frequencv of diarrhea.
1his studv was approved bv the Commission on
Medical Research lthics and Health, Oadjah Mada
Universitv Medical School. All subjects' parents
provided written informed consent.
Data was analvzed with SPSS for Windows
16.O. 1he effect of tvndallized probiotics with WH
standard therapv was analvzed bv independent
t-test and Chi-square test. Results were considered
statisticallv si,nificant if P < O.O5 with a 95'
confidence interval (Cl).
Results
1here were 1OO subjects divided into two ,roups.
Characteristics of subjects are shown in Table 1.
1here were no si,nificant differences in the
duration or frequencv of diarrhea between the two
,roups as shown in Table 2. Mean duration of diarrhea
in the probiotic ,roup was 1.6 2.3 davs, while that
of the WH standard therapv ,roup was 3.95 1.3
davs (P ~ O.9o). 1he frequencv of diarrhea after the
fifth dav of treatment was 1.56 (SD O.67) times/dav
in the probiotic ,roup, and 1.9 (SD O.99) times/dav
in the WH standard therapv ,roup (P ~ O.1O6). ln
this studv, no side effects, such as sepsis or bacteremia
due to the use of tvndallized probiotics, were observed.
Accordin, to parents' and nurses' reports, all subjects
received their therapv with a 1OO' compliance.
Discussion
1he addition of tvndallized probiotics did not
shorten the duration or reduce the frequencv of
acute diarrhea. Several meta-analvsis studies have
concluded that the addition of probiotics can reduce
the duration of diarrhea, however, these studies used
live probiotics.
5,6,7
Results similar to ours were obtained bv Khanna
et al
1O
in lndia and Pramono et al
11
in lndonesia.
Accordin, to Khanna et al, to observe a therapeutic
effect from probiotics, microbial colonization
should have occurred before their administration.
Table 1. Baseline characteristics of subjects
Characteristics
WHO standard therapy
+ tyndallized probiotic
n = 50
WHO standard therapy
alone
n = 50
Male gender, n (%)
Mean age, months (SD)
Dehydration status
Not dehydrated, n (%)
Dehydrated, n (%)
Mean diarrhea frequency, n (SD)
Nutritional status
Well-nourished, n (%)
Undernourished, n (%)
29(58.0)
17.46 (15.82)
36 (72)
14(28)
7.20 ( 2.16)
30 (60)
20 (40)
25(50)
12.74 (9.84)
30 (60)
20(40)
7.26(2.0)
30(60)
20(40)
Table 2. Diarrhea duration and frequency
Results
WHO standard therapy
+ tyndallized probiotics
WHO standard
therapy alone
P*
Mean duration of diarrhea, days (SD)
Mean frequency of diarrhea on 5th day, times/day (SD)
4.60 (2.3)
1.56 (0.67)
3.95 (1.3)
1.90 (0.99)
0.98
0.11
*t-test
Kesatrianita MF et al: lffect of addin, tvndallized probiotics to the WH standard therapv for acute diarrhea in children
94 Paediatr Indones, Vol. 52, No. 2, March 2012
However, microbial colonization means the duration
of diarrhea would be lon,er. ln acute diarrhea,
colonization mav not vet have taken place, so the
addition of tvndallized probiotics would not provide
the optimal effect.
12
Since stool cultures were not examined, we do
not know the microbial patho,ens causin, diarrhea
in our studv. lrom past stool examination studies,
probiotics were reported to provide ,ood therapeutic
effect on rotavirus diarrhea.
9
A limitation of our studv was the lack of
intensive supervision after treatment administration
to each ,roup. As such, co-intervention mav have
occurred bevond our monitorin, efforts due to the
exchan,e of information between studv ,roups.
lurthermore, with the sin,le-blind studv desi,n, studv
contamination between ,roups mav have occurred if
parents or relatives ,ave other dru,s to the subjects,
influencin, the outcome of the studv. 1herefore,
further research mav be needed, usin, a lar,er sample
size and more intensive monitorin, for each subject.
Nevertheless, our results were similar to previous
research, concludin, that tvndallized probiotics did
not reduce the duration and frequencv of acute
diarrhea in children.
1here were no si,nificant differences in
duration and frequencv of diarrhea between the
WH standard therapv ,roup and the WH
standard therapv with tvndallized probiotics
,roup.
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