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

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.

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Contributions

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.

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Correspondence to Yvan Vandenplas.

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Hegar, B., Waspada, I.M.I., Gunardi, H. et al. A Double Blind Randomized Trial Showing Probiotics to be Ineffective in Acute Diarrhea in Indonesian Children. Indian J Pediatr 82, 410–414 (2015). https://doi.org/10.1007/s12098-014-1408-5

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Keywords

  • Acute diarrhea
  • Acute gastroenteritis
  • Lactobacillus
  • Oral rehydration (solution)
  • Probiotic
  • Zinc