Skip to main content
Erschienen in: The Indian Journal of Pediatrics 5/2015

01.05.2015 | Original Article

A Double Blind Randomized Trial Showing Probiotics to be Ineffective in Acute Diarrhea in Indonesian Children

verfasst von: Badriul Hegar, I. Made Indra Waspada, Hartono Gunardi, Yvan Vandenplas

Erschienen in: Indian Journal of Pediatrics | Ausgabe 5/2015

Einloggen, um Zugang zu erhalten

Abstract

Objective

To investigate the efficacy of probiotics added to oral rehydration solution and zinc in the treatment of acute infectious diarrhea in Indonesian children.

Methods

A prospective randomized double blind placebo-controlled trial was performed to test the efficacy of a probiotic food supplement in 112 children in the Kenari subdistrict, central Jakarta, aged 6–36 mo with acute infectious diarrhea and moderate dehydration. The supplemented group was given standard therapy (oral rehydration solution and zinc) and the probiotic strains Lactobacillus (L.) rhamnosus R0011 1.9 × 109 colony forming units (cfu) and L. acidophilus R0052 0.1 × 109 cfu/d for 7 d, while the control group was given standard therapy and placebo.

Results

Median duration of diarrhea was 68.5 h (range 13–165) in the supplemented and 61.5 h (range 21–166) in the control group (P = 0.596). Median daily frequency of defecation until diarrhea stopped was 5.0 in the supplemented vs. 5.5 in the control group (P = 0.795).

Conclusions

This probiotic food supplement tested did not reduce the duration of acute infectious diarrhea as compared to oral rehydration and zinc.
Literatur
2.
Zurück zum Zitat Dekate P, Jayashree M, Singhi SC. Management of acute diarrhea in emergency room. Indian J Pediatr. 2013;80:235–46.CrossRefPubMed Dekate P, Jayashree M, Singhi SC. Management of acute diarrhea in emergency room. Indian J Pediatr. 2013;80:235–46.CrossRefPubMed
3.
Zurück zum Zitat Hoque KM, Binder HJ. Zinc in the treatment of acute diarrhea: Current status and assessment. Gastroenterology. 2006;130:2201–5.CrossRefPubMed Hoque KM, Binder HJ. Zinc in the treatment of acute diarrhea: Current status and assessment. Gastroenterology. 2006;130:2201–5.CrossRefPubMed
4.
Zurück zum Zitat Patro B, Golicki D, Szajewska H. Meta-analysis: Zinc supplementation for acute gastroenteritis in children. Aliment Pharmacol Ther. 2008;28:713–23.CrossRefPubMed Patro B, Golicki D, Szajewska H. Meta-analysis: Zinc supplementation for acute gastroenteritis in children. Aliment Pharmacol Ther. 2008;28:713–23.CrossRefPubMed
5.
Zurück zum Zitat Salvatore S, Hauser B, Devreker T, Vieira MC, Luini C, Arrigo S, et al. Probiotics and zinc in acute infectious gastroenteritis in children: Are they effective? Nutrition. 2007;23:498–506.CrossRefPubMed Salvatore S, Hauser B, Devreker T, Vieira MC, Luini C, Arrigo S, et al. Probiotics and zinc in acute infectious gastroenteritis in children: Are they effective? Nutrition. 2007;23:498–506.CrossRefPubMed
6.
Zurück zum Zitat Pieścik-Lech M, Shamir R, Guarino A, Szajewska H. Review article: The management of acute gastroenteritis in children. Aliment Pharmacol Ther. 2013;37:289–303.CrossRefPubMed Pieścik-Lech M, Shamir R, Guarino A, Szajewska H. Review article: The management of acute gastroenteritis in children. Aliment Pharmacol Ther. 2013;37:289–303.CrossRefPubMed
7.
Zurück zum Zitat Guarino A, Albano F, Ashkenazi S, Gendrel D, Hoekstra JH, Shamir R, et al. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe. J Pediatr Gastroenterol Nutr. 2008;46:S81–122.CrossRefPubMed Guarino A, Albano F, Ashkenazi S, Gendrel D, Hoekstra JH, Shamir R, et al. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe. J Pediatr Gastroenterol Nutr. 2008;46:S81–122.CrossRefPubMed
8.
Zurück zum Zitat Heaton KW, Radvan J, Cripps H, Mountford RA, Braddon FE, Hughes AO. Defecation frequency and timing, and stool form in the general population: A prospective study. Gut. 1992;33:818–24.CrossRefPubMedCentralPubMed Heaton KW, Radvan J, Cripps H, Mountford RA, Braddon FE, Hughes AO. Defecation frequency and timing, and stool form in the general population: A prospective study. Gut. 1992;33:818–24.CrossRefPubMedCentralPubMed
9.
Zurück zum Zitat Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997;32:920–4.CrossRefPubMed Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997;32:920–4.CrossRefPubMed
10.
Zurück zum Zitat Thomas DW, Greer FR; American Academy of Pediatrics Committee on Nutrition, American Academy of Pediatrics Section on Gastroenterology. Probiotics and prebiotics in pediatrics. Pediatrics. 2010;126:1217–31.CrossRefPubMed Thomas DW, Greer FR; American Academy of Pediatrics Committee on Nutrition, American Academy of Pediatrics Section on Gastroenterology. Probiotics and prebiotics in pediatrics. Pediatrics. 2010;126:1217–31.CrossRefPubMed
11.
Zurück zum Zitat Vandenplas Y, De Hert SG, PROBIOTICAL-study group. Randomised clinical trial: The synbiotic food supplement probiotical vs. Placebo for acute gastroenteritis in children. Aliment Pharmacol Ther. 2011;34:862–7. Vandenplas Y, De Hert SG, PROBIOTICAL-study group. Randomised clinical trial: The synbiotic food supplement probiotical vs. Placebo for acute gastroenteritis in children. Aliment Pharmacol Ther. 2011;34:862–7.
12.
Zurück zum Zitat Allen SJ, Martinez EG, Gregorio GV, Dans LF. Probiotics for treating acute infectious diarrhoea. Cochrane Database Syst Rev. 2010;11: CD003048.PubMed Allen SJ, Martinez EG, Gregorio GV, Dans LF. Probiotics for treating acute infectious diarrhoea. Cochrane Database Syst Rev. 2010;11: CD003048.PubMed
13.
Zurück zum Zitat Shamir R, Makhoul IR, Etzioni A, Shehadeh N. Original research: evaluation of a diet containing probiotics and zinc for the treatment of mild diarrheal illness in children younger than one year of age. J Am Coll Nutr. 2005;24:370–5.CrossRefPubMed Shamir R, Makhoul IR, Etzioni A, Shehadeh N. Original research: evaluation of a diet containing probiotics and zinc for the treatment of mild diarrheal illness in children younger than one year of age. J Am Coll Nutr. 2005;24:370–5.CrossRefPubMed
14.
Zurück zum Zitat Dalgic N, Sancar M, Bayraktar B, Pullu M, Hasim O. Probiotic, zinc and lactose-free formula in children with rotavirus diarrhea: Are they effective? Pediatr Int. 2011;53:677–82.CrossRefPubMed Dalgic N, Sancar M, Bayraktar B, Pullu M, Hasim O. Probiotic, zinc and lactose-free formula in children with rotavirus diarrhea: Are they effective? Pediatr Int. 2011;53:677–82.CrossRefPubMed
15.
Zurück zum Zitat Sazawal S, Jalla S, Mazumder S, Sinha A, Black RE, Bhan MK. Effect of zinc supplementation on cell mediated immunity and lymphocyte subsets in preschool children. Indian Pediatr. 1997;34:689–97. Sazawal S, Jalla S, Mazumder S, Sinha A, Black RE, Bhan MK. Effect of zinc supplementation on cell mediated immunity and lymphocyte subsets in preschool children. Indian Pediatr. 1997;34:689–97.
16.
Zurück zum Zitat Wadhwa N, Natchu UC, Sommerfelt H, Strand TA, Kapoor V, Saini S, et al. ORS containing zinc does not reduce duration or stool volume of acute diarrhea in hospitalized children. J Pediatr Gastroenterol Nutr. 2011;53:161–7.CrossRefPubMed Wadhwa N, Natchu UC, Sommerfelt H, Strand TA, Kapoor V, Saini S, et al. ORS containing zinc does not reduce duration or stool volume of acute diarrhea in hospitalized children. J Pediatr Gastroenterol Nutr. 2011;53:161–7.CrossRefPubMed
17.
Zurück zum Zitat Passariello A, Terrin G, De Marco G, Cecere G, Ruotolos S, Marino A, et al. Effiacy of a new hypotonic oral rehydration solution containing zinc and prebiotics in the treatment of childhood acute diarrhea: A randomized controlled trial. J Pediatr. 2011;158:e1.PubMed Passariello A, Terrin G, De Marco G, Cecere G, Ruotolos S, Marino A, et al. Effiacy of a new hypotonic oral rehydration solution containing zinc and prebiotics in the treatment of childhood acute diarrhea: A randomized controlled trial. J Pediatr. 2011;158:e1.PubMed
18.
Zurück zum Zitat Agustina R, Kok FJ, van de Rest O, Fahmida U, Firmansyah A, Lukito W, et al. Randomized trial of probiotics and calcium on diarrhea and respiratory tract infections in Indonesian children. Pediatrics. 2012;129:1155–64.CrossRef Agustina R, Kok FJ, van de Rest O, Fahmida U, Firmansyah A, Lukito W, et al. Randomized trial of probiotics and calcium on diarrhea and respiratory tract infections in Indonesian children. Pediatrics. 2012;129:1155–64.CrossRef
19.
Zurück zum Zitat Mcfarland LV, Elmer GW, Mcfarland M. Meta-analysis of probiotics for the prevention and treatment of acute pediatric diarrhea. Int J Probiotics Prebiotics. 2006;1:63–76. Mcfarland LV, Elmer GW, Mcfarland M. Meta-analysis of probiotics for the prevention and treatment of acute pediatric diarrhea. Int J Probiotics Prebiotics. 2006;1:63–76.
20.
Zurück zum Zitat Riaz M, Alam S, Malik A, Ali SM. Efficacy and safety of Saccharomyces boulardii in acute childhood diarrhoea: A double blind randomised controlled trial. Indian J Pediatr. 2012;79:478–82.CrossRefPubMed Riaz M, Alam S, Malik A, Ali SM. Efficacy and safety of Saccharomyces boulardii in acute childhood diarrhoea: A double blind randomised controlled trial. Indian J Pediatr. 2012;79:478–82.CrossRefPubMed
21.
Zurück zum Zitat Narayanappa D. Randomized double blinded controlled trial to evaluate the efficacy and safety of Bifilac in patients with acute viral diarrhea. Indian J Pediatr. 2008;75:709–13.CrossRefPubMed Narayanappa D. Randomized double blinded controlled trial to evaluate the efficacy and safety of Bifilac in patients with acute viral diarrhea. Indian J Pediatr. 2008;75:709–13.CrossRefPubMed
22.
23.
Zurück zum Zitat Salazar-Lindo E, Miranda- Langschwager P, Campos-Sanchez M, Woo Chea E, Sack RB. Lactobacillus casei strain GG in the treatment of infants with acute watery diarrhea: A randomized, double-blind, placebo controlled clinical trial [ISRCTN67363048]. BMC Pediatr. 2004;4:18. Salazar-Lindo E, Miranda- Langschwager P, Campos-Sanchez M, Woo Chea E, Sack RB. Lactobacillus casei strain GG in the treatment of infants with acute watery diarrhea: A randomized, double-blind, placebo controlled clinical trial [ISRCTN67363048]. BMC Pediatr. 2004;4:18.
24.
Zurück zum Zitat Tlaskal P, Schramlova J, Kokesova A, Adamus J, Bubakova D, Kocnarova N. Probiotics in the treatment of diarrhoeal disease of children. NAFAS. 2005;3:25–8. Tlaskal P, Schramlova J, Kokesova A, Adamus J, Bubakova D, Kocnarova N. Probiotics in the treatment of diarrhoeal disease of children. NAFAS. 2005;3:25–8.
25.
Zurück zum Zitat Tlaskal P, Michkova E, Klayarova H, Jerabkova L, Nevoral J, Balackova J. Lactobacillus acidophilus in the treatment of children with gastrointestinal tract illness. Cesk Pediatr. 1995;51:615–9. Tlaskal P, Michkova E, Klayarova H, Jerabkova L, Nevoral J, Balackova J. Lactobacillus acidophilus in the treatment of children with gastrointestinal tract illness. Cesk Pediatr. 1995;51:615–9.
26.
Zurück zum Zitat Dianawati D, Shah NP. Survival, acid and bile tolerance, and surface hydrophobicity of microencapsulated B. animalis ssp. lactis Bb12 during storage at room temperature. J Food Sci. 2011;76:592–9.CrossRef Dianawati D, Shah NP. Survival, acid and bile tolerance, and surface hydrophobicity of microencapsulated B. animalis ssp. lactis Bb12 during storage at room temperature. J Food Sci. 2011;76:592–9.CrossRef
27.
Zurück zum Zitat Vanhee LM, Goemé F, Nelis HJ, Coenye T. Quality control of fifteen probiotic products containing Saccharomyces boulardii. J Appl Microbiol. 2010;109:1745–52.PubMed Vanhee LM, Goemé F, Nelis HJ, Coenye T. Quality control of fifteen probiotic products containing Saccharomyces boulardii. J Appl Microbiol. 2010;109:1745–52.PubMed
28.
Zurück zum Zitat Rerksuppaphol S, Rerksuppaphol L. Lactobacillus acidophilus and bifidobacterium bifidum stored at ambient temperature are effective in the treatment of acute diarrhoea. Ann Trop Paediatr. 2010;30:299–304.CrossRefPubMedCentralPubMed Rerksuppaphol S, Rerksuppaphol L. Lactobacillus acidophilus and bifidobacterium bifidum stored at ambient temperature are effective in the treatment of acute diarrhoea. Ann Trop Paediatr. 2010;30:299–304.CrossRefPubMedCentralPubMed
29.
Zurück zum Zitat Institut Rosell. M2 ctd Summaries, summary of information contained in the ctd registration file for the product lacidofil capsules. Supporting Information for the registration of the product lacidofil capsules in Indonesia. 2005. Institut Rosell. M2 ctd Summaries, summary of information contained in the ctd registration file for the product lacidofil capsules. Supporting Information for the registration of the product lacidofil capsules in Indonesia. 2005.
30.
Zurück zum Zitat Guarino A, Dupont C, Gorelov AV, Gottrand F, Lee JK, Lin Z, et al. The management of acute diarrhea in children in developed and developing areas: From evidence base to clinical practice. Expert Opin Pharmacother. 2012;13:17–26.CrossRefPubMed Guarino A, Dupont C, Gorelov AV, Gottrand F, Lee JK, Lin Z, et al. The management of acute diarrhea in children in developed and developing areas: From evidence base to clinical practice. Expert Opin Pharmacother. 2012;13:17–26.CrossRefPubMed
Metadaten
Titel
A Double Blind Randomized Trial Showing Probiotics to be Ineffective in Acute Diarrhea in Indonesian Children
verfasst von
Badriul Hegar
I. Made Indra Waspada
Hartono Gunardi
Yvan Vandenplas
Publikationsdatum
01.05.2015
Verlag
Springer India
Erschienen in
Indian Journal of Pediatrics / Ausgabe 5/2015
Print ISSN: 0019-5456
Elektronische ISSN: 0973-7693
DOI
https://doi.org/10.1007/s12098-014-1408-5

Weitere Artikel der Ausgabe 5/2015

The Indian Journal of Pediatrics 5/2015 Zur Ausgabe

Editorial Commentary

Probiotics in Pediatrics

Kinder mit anhaltender Sinusitis profitieren häufig von Antibiotika

30.04.2024 Rhinitis und Sinusitis Nachrichten

Persistieren Sinusitisbeschwerden bei Kindern länger als zehn Tage, ist eine Antibiotikatherapie häufig gut wirksam: Ein Therapieversagen ist damit zu über 40% seltener zu beobachten als unter Placebo.

Neuer Typ-1-Diabetes bei Kindern am Wochenende eher übersehen

23.04.2024 Typ-1-Diabetes Nachrichten

Wenn Kinder an Werktagen zum Arzt gehen, werden neu auftretender Typ-1-Diabetes und diabetische Ketoazidosen häufiger erkannt als bei Arztbesuchen an Wochenenden oder Feiertagen.

Neue Studienergebnisse zur Myopiekontrolle mit Atropin

22.04.2024 Fehlsichtigkeit Nachrichten

Augentropfen mit niedrig dosiertem Atropin können helfen, das Fortschreiten einer Kurzsichtigkeit bei Kindern zumindest zu verlangsamen, wie die Ergebnisse einer aktuellen Studie mit verschiedenen Dosierungen zeigen.

Spinale Muskelatrophie: Neugeborenen-Screening lohnt sich

18.04.2024 Spinale Muskelatrophien Nachrichten

Seit 2021 ist die Untersuchung auf spinale Muskelatrophie Teil des Neugeborenen-Screenings in Deutschland. Eine Studie liefert weitere Evidenz für den Nutzen der Maßnahme.

Update Pädiatrie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.