pediatric journal 8

7/26/2019 Pediatric Journal 8

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Clinical StudyThe 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

Department of Pediatrics, Zanjan Metabolic Disease Research Center, Zanjan University of Medical Sciences, Zanjan, Iran Zanjan University of Medical Sciences, Zanjan, Iran Department of Pediatrics, Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran Department of Epidemiology, Zanjan University of Medical Sciences, Zanjan, Iran

Department of Pediatrics, Zanjan University of Medical Sciences, Zanjan, Iran

Correspondence should be addressed to P. Khoshnevisasl; [email protected]

Received December ; Revised February ; Accepted February ; Published April

Academic Editor: Joel R. Rosh

Copyright M. Sadeghzadeh et al. Tis is an openaccess article distributed under the CreativeCommons AttributionLicense,which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background. Inconsistent data exist about the role o probiotics in the treatment o constipated children. Te aim o this studywas to investigate the effectiveness o probiotics in childhood constipation.Materials and Methods. In this placebo controlled trial,fy-six children aged years with constipation received randomly lactulose plus Protexin or lactulose plus placebo daily orour weeks. Stool requency and consistency, abdominal pain, ecal incontinence, and weight gain were studied at the beginning,

afer the rst week, and at the end o the th week in both groups. Results. Forty-eight patients completed the study. At the end othe ourth week, the requency and consistency o deecation improved signicantly ( = 0.042and = 0.049, resp.). At the endo the rst week, ecal incontinence and abdominal pain improved signicantly in intervention group ( = 0.030and = 0.017,resp.) but, at the end o the ourth week, this difference was not signicant ( = 0.125and = 0.161, resp.). A signicant weightgain was observed at the end o the st week in the treatment group.Conclusion. Tis study showed that probiotics had a positiverole in increasing the requency and improving the consistency at the end o th week.

1. Introduction

Constipation is a common disorder in children and could

have a destructive effect on the physical as well as psycho-logical aspects o health []. Its prevalence varies rom .%to .% in different studies []. Organic causes cannot beound in more than % o cases[]. Constipation is denedas the painul passage o stool less than twice a week or lessthan once every three days []. Usual treatments includingtoilet training, amily education, dietary changes, and the useo laxatives, although useul, are not completely satisactory[, ]. Tereore, there is a growing interest to nd a newsolution[].

Currently, probiotics were used as an adjunctive treat-ment or a lot o childhood diseases. Te role o probioticsin gastrointestinal diseases as well as allergic disorders, atopic

dermatitis, prevention o inections,necrotizing enterocolitis,and inantile colic was shown in many studies[].

It seems that probiotics, which are live microbial ingre-

dients, produce lactic and acetic acids and inuence theperistalsis o intestines by reducing colonic pH[,].

Although the role o probiotics is well studied in adults,there were ew data on its effectiveness in childhood consti-pation with contradictory results [,,,]. Tereore, weconducted this study to evaluate the role o probiotics on ourconstipated patients.

2. Materials and Methods

Tis randomized double blind controlled study was con-ducted on children years old with chronic consti-pation who were reerred to Ayatollah Moussavi hospital

Hindawi Publishing CorporationInternational Journal of PediatricsVolume 2014, Article ID 937212, 5 pageshttp://dx.doi.org/10.1155/2014/937212
http://dx.doi.org/10.1155/2014/937212http://dx.doi.org/10.1155/2014/937212


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International Journal o Pediatrics

: Demographic characteristics o patients.

Variables Intervention group Control group otal value

Gender

Male (.%) (.%) (%)( = 0.248)

Female (.%) (.%) (%)

Mean age (year) 6.1 2.4 6.3 1.9 ( = 0.739)

clinics in Zanjan, Iran, rom October to March . Allchildren ullled Rome III criteria or chronic constipation.Te exclusion criteria consisted o any underlying diseases,history o hospital admission, or any gastrointestinal ornutritional problems other than constipation. Tis study wasapproved by the Medical Ethics Committee o Zanjan Uni-

versity o Medical Sciences (Ethical code: ). Inormedwritten consent was signed by parents o all patients beoreany intervention.

Te sample size was calculated by the ormula =[1/2+ 1]

2[1(1 1) + 2(1 2)]/(1 2)2 based

on1 = 89%,2 = 56%, = 0/05,1 = 0/80, = 1/95,and /, respectively( = 56).

Te patients were randomly allocated into two groupswho received lactulose ( mL/kg/d) plus Protexin (NikootebCompany, ehran, Iran) one sachet daily or lactulose plusplacebo alone orour month. Te control group was matchedaccording to sex and age.

A period o one week was estimated as a wash-outperiod or those who used any drugs or their constipation.Each sachet o Protexin was composed o seven probioticbacteria including Lactobacillus casei PXN , Lactobacillus

rhamnosus PXN , Streptococcus thermophiles PXN ,Bidobacterium breve PXN, Lactobacillus acidophilus PXN, Bidobacterium infantis (child specic) PXN , andLactobacillus bulgaricus PXN , VC: billion CFU VC:

1 109. Te placebo was supplied by Nikooteb company, theprovidero probiotics in Iran, as innocent powder in identicalsachets and stored in a cool and dry place until use.

Each patient was visited by the researcher and completelyevaluated or organic diseases, and a questionnaire includ-ing demographic data, past medical history, drug history,symptoms o constipation, and physical examination wascompleted beore the study. Te patients with comorbidconditions were excluded rom the study.

Afer the rst and ourth weeks o intervention, a secondquestionnaire was completed or symptoms o constipationincluding the requency o deecation, stool consistency,abdominal pain, requency o ecal incontinence, and sideeffects in both groups. Fecal requency, consistency (hard,normal, and sof), and weight gain o all patients wererecorded. Fecal incontinence and abdominal pain werelooked or only in patients who had these symptoms beorethe intervention.

Data were analyzed using SPSS sofware Version ..Number o bowel movements and ecal incontinenceepisodes in baseline inormation were analyzed by Freidmantest. Te Students -test was used or parametric data and

chi-square analysis was used or categorical measures. value o


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: Comparison o symptoms between the beginning and end o the st and th weeks.

Variables reatment (meanSD) Placebo (meanSD) value

Stool requency

Beginning to st week 1.67 0.82 0.79 0.83

.Beginning to th week 2.08 0.65 1.54 0.98

st to th week 0.92 0.72 0.75 0.61

Stool consistencyBeginning to st week 0.42 0.50 0.21 0.41

.Beginning to th week 0.88 0.45 0.63 0.50

st to th week 0.46 0.51 0.42 0.50Stool consistency: : hard, : normal, and : sof.

: Symptom changes at the end o the st week.

Symptom reatment requency, percent Placebo requency, percent value

With ecal incontinence (.%) (.%)

.Without ecal incontinence (.%) (.%)

otal (ecal incontinence) (%) (%)

With abdominal pain (.%) (.%)

.Without abdominal pain (.%) (.%)otal (abdominal pain) (%) (%)

With weight gain (.%) (.%)

.Without weight gain (.%) (.)

otal weight gain (%) (%)

gut microora, and inuence the peristalsis o intestines[,].

Our study showed that probiotics were signicantlyeffective in improving the stool requency and consistency inintervention group at the end o the th week. A signicant

decrease in ecal incontinence and abdominal pain andincreasing bodyweight were ound by theend o the rst weekin treatment group which was not signicant at the end othe th week. Tere are many studies with the same results[,,].

Te study o Saneian comparing placebo plus mineral oilandprobiotics plus mineral oil on patients in Isahan, Iran,revealed that stool requency, consistency, pain at deecation,and soiling improved signicantly in intervention group [].

Te study o Bekkali on twenty -year-old childrenreceiving probiotics revealed that, afer weeks, the re-quency o bowl movements had been increased and a signi-icant decrease in ecal incontinence and abdominal pain was

observed []. Tese results are similar to our results.Koebnick concluded that at the end o th week

% oconstipated patients receiving probiotics signicantlyimproved compared to % o controls[].

Te study o Ardatskaia on patients having irritablebowel syndrome with predominance o constipation showedthat Normoorin therapy had normalized the intestinalmotor activity through changes in microbial ora o theintestines [].

In a crossover trial conducted in Brazil by Guerra,studying constipated students, afer weeks, the caseswho received probiotic yogurt had signicant improvementin deecation requency ( = 0.012), deecation pain( =

0.046), and abdominal pain ( = 0.015) compared tostudents who get only yogurt [].

Jayasimhan had studied adults with constipation andollowed them afer days. He concluded that probiotics hadsignicantly improved stool requency and consistency[].

Tese results are similar to our results at the end o the rstweek.

Te study o Khodadad in ehran on constipatedchildren showed that probiotic plus mineral oil increasedstool requency signicantly comparing with mineral oil plusplacebo and probiotic plus placebo. On the other hand, stoolconsistency, abdominal pain, and ecal incontinence wereimproved, although the difference was not signicant. Teresults o this study were similar to our investigation butimprovemento stool consistency was signicant in ourstudy[].

In a meta-analysis by Miller and Ouwehand, probioticshad a short-term effect on reducing intestinal transit time in

constipated adults. A greater effect on patients with versuswithout constipation and older versus younger was shown[].

In all these studies, stool requency has been improvedwhich could be due to change in intestinal ora, althoughew studies have reevaluated gut microora []. Althoughthe differences in improvement o various symptoms couldbe due to regimens used by patients, the mixture o pre- andprobiotics and different bacteria used can also explain thesediversities. Te decrease in ecal incontinence and abdominalpain and increasing body weight that was ound by the end othe rst week in treatmentgroup but notsignicant at the endo the th week could be explained by the chronic nature o


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the disease, a better effect o this drug in short term, and thetolerance to treatment.

Conversely, there are some studies which are not similarto our ndings:

Vandenplas et al. stated that probiotics had limited role incontrolling the constipation, although its role in antibiotic-

associated diarrhea and acute gastroenteritis was conrmed[].Banaszkiewicz and Szajewska had studied eighty-

our constipated children ( years o age) receiving

mL/kg/day o % lactulose plus 9 colony-orming units(CFU) oLactobacillus GG (LGG) orally twice daily or weeks comparing with a control group and concluded thatLGG was not an effective adjunct to lactulose in childrenwith constipation []. We have used lactulose in our patientstoo, because it was well tolerated and easily accessible anddifferent results may be due to the composition o probioticsused.

Mazlyn and coworkers demonstrated that adults with

unctional constipation did not have signicant alleviationin constipation severity or stool requency, consistency, andquantity comparing to controls afer weeks o treatmentwith probiotics [].

Te study o abbers et al. on constipated childrenreceiving ermented dairy product containing Bidobac-terium lactis strain showed that, in spite o improvement instool requency comparing to baseline, the result was notcomparable to controls [].

Considering these controversies, it seems that largerstudies are needed to clariy the effect o probiotics in con-stipation. It is recommended to control strictly the regimensused in both groups, and it seems that a mixture o pre- andprobiotics containing all useul ora would be promising.

Also, we ound a signicant increase in body weightwhich was not mentioned in other studies and it may be dueto improved appetite afer decreasing intestinal transit time.Further investigations are needed to prove this effect.

5. Conclusion

Tis investigation revealed signicantly increased bowel re-quency and improved stoolconsistency with the combinationo lactulose and probiotics. In our study, the decrease inepisodes o ecal incontinence and abdominal pain wassignicant compared to control group at the end o the rstweek that may be due to a better effect o this drug in shortterm.

Conflict of Interests

Tere is no conict o interests.

Acknowledgments

Tis project was a thesis or a pediatric specialty degreeand was ounded by the Research Department o ZanjanUniversity o Medical Sciences. Te authors greatly appreciateall participants in this study. Tey also appreciate the helpulcomments o Dr. Akeeh Ahmadiashar in editing this paper.

References

[] H. Saneian, K. avakkol, P. Adhamian, and A. Gholamrezaei,Comparison oLactobacillus sporogenes plus mineral oil andmineral oil alone in the treatment o childhood unctionalconstipation,Journalof Researchin Medical Sciences, vol., no., pp. , .

[] S. M. Mugie, C. di Lorenzo, and M. A. Benninga, Constipationin childhood, Nature ReviewsGastroenterology and Hepatology,vol. , no. , pp. , .

[] N.-L. Bekkali, M. E. J. Bongers, M. M. van den Berg, O. Liem,and M. A. Benninga, Te role o a probiotics mixture in thetreatment o childhood constipation: a pilot study, NutritionJournal, vol. , article , .

[] H. Saneian and N. Mostozadeh, Comparing the efficacy opolyethylene glycol (PEG), magnesium hydroxide and lactulosein treatment o unctional constipation in children,Journal ofResearch in Medical Sciences, vol. , no. , pp. SS, .

[] A. Chmielewska and H. Szajewska, Systematic review orandomised controlled trials: probiotics or unctional consti-

pation, World Journal of Gastroenterology, vol. , no. , pp. , .

[] Y. Vandenplas, E. de Gree, . Devreker, G. Veereman-Wauters,and B. Hauser, Probiotics and prebiotics in inants and chil-dren,Current Infectious Disease Reports, vol. , no. , pp. , .

[] A. Horvath and H. Szajewska, Probiotics, prebiotics, anddietary ber in the management o unctional gastrointestinaldisorders,World Review of Nutrition & Dietetics, vol. , pp., .

[] G. Alvarez-Calatayud, J. Perez-Moreno, M. oln, and C.Sanchez, Clinical applications o the use o probiotics inpediatrics,Nutricion Hospitalaria, vol. , no. , pp. ,

.

[] H. Szajewska, M. Setty, J. Mrukowicz, and S. Guandalini, Pro-biotics in gastrointestinal diseases in children: hard and not-so-hard evidence o efficacy,Journal of Pediatric Gastroenterology& Nutrition, vol. , no. , pp. , .

[] Y. Vandenplas, G. Veereman-Wauters, E. de Gree et al., Pro-biotics and prebiotics in prevention and treatment o diseasesin inants and children, Jornal de Pediatria, vol. , no. , pp., .

[] C. Koebnick, I. Wagner, P. Leitzmann, U. Stern, and H. J.F. Zunf, Probiotic beverage containing Lactobacillus caseiShirota improves gastrointestinal symptoms in patients withchronic constipation, Canadian Journal of Gastroenterology,

vol. , no. , pp. , .

[] M. D. Ardatskaia and O. N. Minushkin, Probiotics in thetreatment o unctional intestinal diseases, Eksperimentalnia iKlinicheskaia Gastroenterologiia , no. , pp. , .

[] P. V. P. Guerra, L. N. Lima, . C. Souza et al., Pediatric unc-tional constipation treatment with bidobacterium-containingyogurt: a crossover, double-blind, controlled trial,World Jour-nal of Gastroenterology, vol. , no. , pp. , .

[] S. Jayasimhan, N.-Y. Yap, Y. Roest, R. Rajandram, and K.-F. Chin, Efficacy o microbial cell preparation in improvingchronic constipation: a randomized, double-blind, placebo-controlled trial,Clinical Nutrition, vol. , no. , pp. ,.


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[] A. Khodadad and M. Sabbaghian, Role o synbiotics in thetreatment o childhood constipation: a double-blind random-ized placebo controlled trial,Iranian Journal of Pediatrics, vol., no. , pp. , .

[] L. E. Miller and A. C. Ouwehand, Probiotic supplementationdecreases intestinal transit time: meta-analysis o randomizedcontrolled trials,World Journal of Gastroenterology, vol. , no., pp. , .

[] A. Banaszkiewicz and H. Szajewska, Ineffectiveness o Lac-tobacillusGG as an adjunct to lactulose or the treatment oconstipation in children: a double-blind, placebo-controlledrandomized trial,Te Journal of Pediatrics, vol. , no. , pp., .

[] M. M. Mazlyn, L. H. Nagarajah, A. Fatimah,A. K. Norimah, andK. L. Goh, Effects o a probiotic ermented milk on unctionalconstipation: a randomized,double-blind, placebo-controlledstudy,Journal of Gastroenterology and Hepatology, vol. , no., pp. , .

[] M. M. abbers, A. Chmielewska, M. G. Roseboom et al.,Fermented milk containing Bidobacterium lactis DN-

in childhood constipation: a randomized, double-blind,controlled trial, Pediatrics, vol. , no. , pp. ee, .

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