A Community-based Randomized Double Blind Controlled Trial of Lactobacillus paracasei and Bifidobacterium lactis on Reducing Risk for Diarrhea and Fever in Preschool Children in an Urban Slum in India

Aims: The aim of the study was to determine the effect of probiotics on diarrhea and fever in preschool children in a community setting in a developing country.
Study Design: Double blind randomized controlled trial.
Place and Duration of Study: The study was performed in Addagutta; a slum of Hyderabad (India), from July 2010 to April 2011.
Methodology: Healthy preschool children (2-5 years, n=379) in an Urban Slum in India. Three randomly allocated groups of children received either of the two probiotics (Lactobacillus paracasei Lpc-37 and Bifidobacterium lactis HN019) or the placebo for a period of 9 months and were assessed for weight gain, linear growth and incidence of diarrhea and fever.
Results: Neither of the tested probiotics; L. paracasei Lpc-37 or B. lactis HN019 had any influence on weight gain or linear growth. There was no significant difference between the groups in incidence of diarrhea and fever when assessing the whole study period. However, during the wet season, in the months of August and September, incidence of diarrhea was significantly higher in placebo group (16.9%) compared to L. paracasei Lpc-37 (11.7 %) and B. lactis HN019 groups (8.4 %). Similarly, the incidence of fever was significantly higher in the month of August in the placebo group (11.5%) compared to the L. paracasei Lpc-37 group (7%) and B. lactis HN019 group (7.3%). Probiotic supplementation had no effect on fecal calprotectin, but fecal IgA and serum interleukin 8 were decreased significantly in the B. lactis HN019 group compared to placebo. Consumption of L. paracasei Lpc 37 lead to increased levels of fecal L. paracasei.
Conclusion: During the rainy season, when incidence of fever and diarrhea was highest, the administered probiotics reduced the incidence of these symptoms. Over the whole study period, the probiotics did, however, not influence incidence of diarrhea or fever.