A Double Blind Randomized Trial Showing Probiotics to be Ineffective in Acute Diarrhea in Indonesian Children
- 462 Downloads
To investigate the efficacy of probiotics added to oral rehydration solution and zinc in the treatment of acute infectious diarrhea in Indonesian children.
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.
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).
This probiotic food supplement tested did not reduce the duration of acute infectious diarrhea as compared to oral rehydration and zinc.
KeywordsAcute diarrhea Acute gastroenteritis Lactobacillus Oral rehydration (solution) Probiotic Zinc
BH, IMIW, HG and YV: Designed the study; IMIW, HG: Included the patients; BH and YV: Wrote the manuscript. YV will act as guarantor for this paper.
Conflict of Interest
YV is consultant for Biocodex and United Pharmaceuticals.
Role of Funding Source
Dexa Medica (Jakarta, Indonesia) provided the probiotics and Indofarma (Jakarta, Indonesia) zinc and ORS for free.
- 1.The United Nations Children’s Fund/World Health Organization. WHO/UNICEF joint statement: clinical management of acute diarrhea. 2004. [cited 2008 April 1]. Available from http://www.mostproject.org/ZINC/WHO-UNICEF%20Statement.pdf
- 7.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.CrossRefPubMedGoogle Scholar
- 11.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.Google Scholar
- 15.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.Google Scholar
- 19.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.Google Scholar
- 23.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.Google Scholar
- 24.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.Google Scholar
- 25.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.Google Scholar
- 29.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.Google Scholar