Randomized Trial of Probiotics and Calcium on Diarrhea and Respiratory Tract

Infections in Indonesian Children

Rina Agustina, Frans J. Kok, Ondine van de Rest, Umi Fahmida, Agus
Firmansyah, Widjaja Lukito, Edith J. M. Feskens, Ellen G. H. M. van den Heuvel,
Ruud Albers and Ingeborg M. J. Bovee-Oudenhoven
Pediatrics 2012;129;e1155; originally published online April 9,
2012; DOI: 10.1542/peds.2011-1379
The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/129/5/e1155.full.html
PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly
publication, it has been published continuously since 1948. PEDIATRICS is owned, published,
and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk
Grove Village, Illinois, 60007. Copyright 2012 by the American Academy of Pediatrics. All
rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
Downloaded from pediatrics.aappublications.org at Indonesia:AAP Sponsored on October 7, 2013
Randomized Trial of Probiotics and Calcium on Diarrhea and Respiratory Tract
Infections in Indonesian Children
Rina Agustina, Frans J. Kok, Ondine van de Rest, Umi Fahmida, Agus
Firmansyah, Widjaja Lukito, Edith J. M. Feskens, Ellen G. H. M. van den Heuvel,
Ruud Albers and Ingeborg M. J. Bovee-Oudenhoven
Pediatrics 2012;129;e1155; originally published online April 9,
2012; DOI: 10.1542/peds.2011-1379
Updated Information & including high resolution figures, can be found at:
Services http://pediatrics.aappublications.org/content/129/5/e1155.full.
html
References This article cites 50 articles, 17 of which can be accessed free
at:
http://pediatrics.aappublications.org/content/129/5/e1155.full.
html#ref-list-1
Citations This article has been cited by 1 HighWire-hosted articles:
http://pediatrics.aappublications.org/content/129/5/e1155.full.
html#related-urls
Subspecialty Collections This article, along with others on similar topics, appears in
the following collection(s):
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http://pediatrics.aappublications.org/cgi/collection/internation
al_child_health_sub
Pharmacology
http://pediatrics.aappublications.org/cgi/collection/pharmacol
ogy_sub
Permissions & Licensing Information about reproducing this article in parts (figures,
tables) or in its entirety can be found online at:
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tml
Reprints Information about ordering reprints can be found online:
http://pediatrics.aappublications.org/site/misc/reprints.xhtml
PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly
publication, it has been published continuously since 1948. PEDIATRICS is owned,
published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point
Boulevard, Elk Grove Village, Illinois, 60007. Copyright 2012 by the American Academy
of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
Downloaded from pediatrics.aappublications.org at Indonesia:AAP Sponsored on October 7, 2013
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TA/LE 8 /aseline Characteristics of the Indonesian Children Accordin# to Assi#ned Treatment
Characteristic LC RC Casei Reuteri
5n I 78B6 5n I 78E6 5n I 78<6 5n I 78B6
Li+in# in floodin# area$ n 5H6 @75E;6 @85E;6 C@ 5E;6 @85EE6
%ale$ n 5H6 EC5;B6 E@5;B6 EE 5;;6 E@5;;6
A#e$ mean E !D$ mo ;9(DE 7B(D ;@(9E 7B(8 E<(D E 7D(C ;@(9E 7;(7
&amily size$ mean E !D ;(7E 7(C ;(BE 7(C ;(8 E 7(@ ;(<E 7(@
Household e>penditure$ mean E !D$ U!FAmo
a
7@9E 9C 79BE 7D9 7;9 E E9 8<DE 7@7
%otherGs education $E y$ n 5H6 BD5D;6 BD5DB6 ;8 5BD6 ;<5B<6
Diarrhea 8 2* before study$ n 5H6 8<57E6 7D57<6 8B 58<6 7;5786
ARTI 8 2* before study$ n 5H6
b
B@5D96 ;75B<6 ;8 5BD6 ;E5B;6
!erum H!0CRP$ median 5I1R6$ m#AL <(C95<(8D?7(@86 <(C;5<(8@?8(9<6 <(C; 5<(D<?8(;<6 <(EE5<(8;?D(<D6
!erum A.P$ median 5I1R6$ #AL <(C95<(E9?<(9D6 <(@85<(C<?<(9;6 <(@D 5<(C<?<(9C6 <(@75<(C7?<(9B6
Anemia$ n 5H6 8B5796 DD58E6 8B 58<6 8B5796
:utritional status
,ei#ht0for0a#e z score$ mean E !D 87(8CE 7(7 87(B<E <(9 87(7; E 7(7 87(8EE 7(8
Hei#ht0for0a#e z score$ mean E !D 87(;DE 7(< 87(E;E <(9 87(D9 E 7(< 87(BCE 7(7
,ei#ht0for0hei#ht z score$ mean E !D 8<(;7E 7(< 8<(;9E 7(8 8<(;@ E 7(< 8<(E;E <(9
&ecal calcium$ median 5I1R6$ m#A# C(E5B(C?77(76 C(;5B(@?7<(B6 E(E 5B(@?9(D6 C(@5;(7?77(B6
Habitual dietary inta*e$
c
mean E !D
Ener#y$ *calAd 7<DDE DE@ 7<EEE D89 7<8B E DE9 9CEE D7<
Protein$ #Ad DB(DE 7D(; DE(DE 78(9 DD(; E 7D(E D8(9E 77(<
Carbohydrate$ #Ad 7;;E ;@ 7;CE B@ 7;E E ;@ 7BEE B9
&at$ #Ad D8(8E 7D(8 DB(;E 7D(9 D7(@ E 7D(C D<(9E 77(B
&iber$ #Ad B(;E D(7 ;(7E D(; B(9 E D(C B(EE 8(@
Calcium$ m#Ad 8D;E 9; 8B7E 9C 88@ E 7<; 88@E 9B
Iron$ m#Ad E(7E 8(C E(EE 8(E E(8 E 8(C E(7E 8(B
Jinc$ m#Ad B(BE 8(< B(@E 7(9 B(B E 8(< B(BE 7(E
A.P$ a70acid #lycoprotein3 H!0CRP$ hi#h0sensiti+ity C0reacti+e protein(
1 !tudentGs t test3 si#nificantly different$ RC +ersus casei and reuteri +ersus casei 5P $ (<;6(
2 >
8
test3 si#nificantly different$ RC +ersus reuteri 5P $ (<;6(
3 Assessed by usin# a semi=uantitati+e food0fre=uency =uestionnaire(
may not be #eneralizable to different settin#s such as our
inter+ention$ 2hich included children of older a#e and in an
urban community settin#(
BB
%oreo+er$ mothers in the study
area usually reported diarrhea 2hen their child defecated F8
looseAli=uid stools$ and broader diarrhea definitions 2ere
applied by other clinical trials(
B;?BC
,e did not only rely on mothersG per0ception but implemented an
acti+e sur+eillance pro#ram to +erify mothersG daily records 2ith
t2ice0a02ee* +isits of trained field 2or*ers and t2ice0a0month
+isits of field super+isors( The physician and monitorin# e>pert
accompanied the field 2or*ers on se+eral of their home +isits( All
end points 2ere as0sessed by usin# structured and pre0tested
forms as applied by others(
8E$89$DC$

D@
The forms 2ere adapted to
the local situation and 2ere used by field 2or*0ers 2ho 2ere
ri#orously trained and super+ised on their application(
Pre+ious e+idence
on the pre+enti+e
ef0fect of
probiotics on
diarrhea and
ARTIs has been
limited to small
studies$ mainly
hospital or day
care center based$
2ith a short follo20
up period and
performed in
de+eloped
countries(
77?7D$B<$B@
There0fore$ our
study in a lo2
socioeconomic
community of a
de+elopin#
country$ 2ith a
much hi#her
number of
sub-ects and
lon#er follo20up$
pro+ides critical
data to help
establish the
rele+ance of
these
inter+entions for
the pre0+ention of
diarrhea in
de+elopin#
countries( To our
*no2led#e$ our
study is the first
lar#e randomized
controlled trial$
focusin# on the
effect of calcium
2ith or 2ithout 7
of 8 spe0cific
probiotics to
reduce diarrhea
and respiratory
tract infections in
these settin#s(
ur results
indicate that the
effect of a
probiotic$ such as
L reuteri
D!%7C9D@$ on
diarrhea is
modified by
nutritional status
and is confined to
children 2ith lo2er
nutritional status(
The rationale for usin# calcium in chil0dren is based on a proof0of0
principle study 2ith adults orally challen#ed 2ith li+e but attenuated
enteroto>i0#enic Escherichia coli( Dietary calcium stron#ly reduced
infection0induced di0arrhea in that study(
@
Animal studies sho2
protecti+e effects a#ainst !almonella as 2ell$
B9$;<
but human
+erification for that findin# is still lac*in#( Rota+irus is re0sponsible for
E<H of hospitalized and B7H of outpatient clinic diarrheal cases in In0
donesian children(
;7
Important bacterial patho#ens amon# children in
de+elopin#
countries are E coli
57<H?8<H6$
!almo0nella 5$;H6$
!hi#ella 5;H?7<H6$
Cam0pylobacter$
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5e>act HGs
un*no2n6(
;8
The
absence of a
beneficial effect of
calcium in our trial
may indicate a
difference in
efficacy bet2een
children and adults
andAor that
protecti+e effects
are patho#en
dependent(
The application of
probiotics to
pre+ent or treat
acute diarrhea is
based on the
e77E< A.U!TI:A
et al
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