Skip to main content

Role of probiotic in preventing acute diarrhoea in children: a community-based, randomized, double-blind placebo-controlled field trial in an urban slum

  • D. SUR (a1), B. MANNA (a1), S. K. NIYOGI (a1), T. RAMAMURTHY (a1), A. PALIT (a1), K. NOMOTO (a2), T. TAKAHASHI (a2), T. SHIMA (a2), H. TSUJI (a2), T. KURAKAWA (a2), Y. TAKEDA (a3), G. B. NAIR (a1) and S. K. BHATTACHARYA (a4)...

Acute diarrhoea remains a major public health challenge in developing countries. We examined the role of a probiotic in the prevention of acute diarrhoea to discover if there was an effect directed towards a specific aetiology. A double-blind, randomized, controlled field trial involving 3758 children aged 1–5 years was conducted in an urban slum community in Kolkata, India. Participants were given either a probiotic drink containing Lactobacillus casei strain Shirota or a nutrient drink daily for 12 weeks. They were followed up for another 12 weeks. The primary outcome of this study was the occurrence of first episodes of diarrhoea. We assessed this during 12 weeks of intake of study agent and also for 12 weeks of follow-up. There were 608 subjects with diarrhoea in the probiotic group and 674 subjects in the nutrient group during the study period of 24 weeks. The level of protective efficacy for the probiotic was 14% (95% confidence interval 4–23, P<0·01 in adjusted model). The reduced occurrence of acute diarrhoea in the probiotic group compared to nutrient group was not associated with any specific aetiology. No adverse event was observed in children of either probiotic or nutrient groups. The study suggests that daily intake of a probiotic drink can play a role in prevention of acute diarrhoea in young children in a community setting of a developing country.

Corresponding author
*Author for correspondence: D. Sur, MBBS, M.D., National Institute of Cholera and Enteric Diseases, P 33 CIT Road, Scheme XM, Beliaghata, Kolkata 700010, India. (Email:
Hide All
1.Girard MP, et al. A review of vaccine research and development: human enteric infections. Vaccine 2006; 24: 27322750.
2.Rudan I, et al. Childhood pneumonia and diarrhoea: setting our priorities right. Lancet Infectious Diseases 2007; 7: 5661.
3.Bhandari N, et al. Substantial reduction in severe diarrhoeal morbidity by daily zinc supplementation in young north Indian children. Pediatrics 2002; 109: e86.
4.Sazawal S, et al. Efficacy of probiotics in prevention of acute diarrhoea: a meta analysis of masked, randomised, placebo control trials. Lancet Infectious Diseases 2006; 6: 374382.
5.Shanahan F. Probiotics: promise, problems, and progress. Gastroenterology & Hepatology Annual Review 2006; 1: 4145.
6.Reid G. The importance of guidelines in the development and application of probiotics. Current Pharmaceutical Design 2005; 11: 1116.
7.Sur D, et al. Periodic deworming with albendazole and its impact on growth status and diarrhoeal incidence among children in an urban slum of India. Transactions of the Royal Society of Tropical Medicine and Hygiene 2005; 99: 261267.
8.WHO. Manual for laboratory identification of acute enteric infections, CDD/83-3/Rev. 1987–113. Geneva, Switzerland: World Health Organisation, 1987.
9.Nguyen TV, et al. Detection and characterization of diarrheagenic Escherichia coli from young children in Hanoi, Vietnam. Journal of Clinical Microbiology 2005; 43: 755760.
10.Yan H, et al. Detection of norovirus (GI, GII), Sapovirus and astrovirus in fecal samples using reverse transcription single-round multiplex PCR. Journal of Virological Methods 2003; 114: 3744.
11.Kiwaki M, Nomoto K. Lactobacillus casei Shirota. In: Lee Y, Salminen S, eds. Handbook of Probiotics and Prebiotics, 2nd edn. New York: John Wiley & Sons, 2008, pp. 449457.
12.Matsumoto K, et al. The effects of a probiotic milk product containing Lactobacillus casei strain Shirota on the defecation frequency and the intestinal microflora of sub-optimal health state volunteers: a randomized placebo-controlled cross-over study. Bioscience and Microflora 2006; 25: 3948.
13.Yokokura T, et al. Enhancement of hematopoietic response of mice by subcutaneous administration of Lactobacillus casei. Infection and Immunity 1986; 52: 156160.
14.Oberhelman RA, et al. A placebo-controlled trial of Lactobacillus GG to prevent diarrhea in undernourished Peruvian children. Journal of Pediatrics 1999; 134: 1520.
15.Ogawa M, et al. Protective effect of Lactobacillus casei strain Shirota on Shiga toxin-producing Escherichia coli O157:H7 infection in infant rabbits. Infection and Immunity 2001; 69: 11011108.
16.Alak JI, et al. Supplementation with Lactobacillus reuteri or L. acidophilus reduced intestinal shedding of cryptosporidium parvum oocysts in immunodeficient C57BL/6 mice. Cell and Molecular Biology (Noisy-le-Grand) 1999; 45: 855863.
17.Guitard J, et al. Experimental study of the effects of probiotics on Cryptosporidium parvum infection in neonatal rats. Parasitology Research 2006; 99: 522527.
18.Pickerd N, Tuthill D. Resolution of cryptosporidiosis with probiotic treatment. Postgraduate Medical Jounal 2004; 80: 112113.
19.Isolauri E, et al. A human Lactobacillus strain (Lactobacillus casei sp. strain GG) promotes recovery from acute diarrhea in children. Pediatrics 1991; 88: 9097.
20.Shornikova AV, et al. Lactobacillus reuteri as a therapeutic agent in acute diarrhea in young children. Journal of Pediatric Gastroenterology Nutrition 1997; 24: 399404.
21.Guandalini S, et al. Lactobacillus GG administered in oral rehydration solution to children with acute diarrhea: a multicenter European trial. Journal of Pediatric Gastroenterology Nutrition 2000; 30: 5460.
22.Saavedra JM, et al. Feeding of Bifidobacterium bifidum and Streptococcus thermophilus to infants in hospital for prevention of diarrhoea and shedding of rotavirus. Lancet 1994; 344: 10461049.
23.Srinivasan R, et al. Clinical safety of Lactobacillus casei shirota as a probiotic in critically ill children. Journal of Pediatric Gastroenterology Nutrition 2006; 42: 171173.
24.Bhatnagar S, et al. IAP Guidelines 2006 on management of acute diarrhea. Indian Pediatrics 2007; 44: 380389.
Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

Epidemiology & Infection
  • ISSN: 0950-2688
  • EISSN: 1469-4409
  • URL: /core/journals/epidemiology-and-infection
Please enter your name
Please enter a valid email address
Who would you like to send this to? *



Altmetric attention score

Full text views

Total number of HTML views: 8
Total number of PDF views: 53 *
Loading metrics...

Abstract views

Total abstract views: 519 *
Loading metrics...

* Views captured on Cambridge Core between September 2016 - 17th December 2017. This data will be updated every 24 hours.