Safety and Efficacy of Bacillus coagulans SNZ 1969® Probiotic Supplementation in Reducing Infections in Malnourished Children: A Randomised, Double-blind, Placebo-controlled Study

Autor: MJ Fernandes, BR Daswani, AA Kinikar, RJ Soman
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Journal of Clinical and Diagnostic Research, Vol 18, Iss 09, Pp 01-06 (2024)
Druh dokumentu: article
ISSN: 2249-782X
0973-709X
DOI: 10.7860/JCDR/2024/73063.19825
Popis: Introduction: Malnutrition, a significant global health challenge, increases children’s susceptibility to infections due to compromised immunity and altered gut microbiota. While probiotics have shown potential in improving gut health and immune responses, their efficacy in malnourished children, particularly those using Bacillus coagulans strains, remains understudied. Aim: To investigate the safety and efficacy of Bacillus coagulans SNZ 1969® among malnourished children aged between one and five years. Materials and Methods: A randomised, double-blind, placebo-controlled study was conducted at Byramjee Jeejeebhoy Government Medical College (BJGMC) and Sassoon Hospitals in Pune, Maharashtra, India among paediatric patients in the outpatient setting, after obtaining ethics committee clearance. Malnourished (moderately underweight) children were randomly allocated to either the probiotic group (B. coagulans SNZ 1969®) or the placebo group receiving the respective treatment for a duration of three months. Total days of illness, as well as the incidence of Gastrointestinal Tract (GIT) and Respiratory Tract Infections (RTIs), were assessed. Results: Out of 82 enrolled children, 46 (24 in the probiotic group and 22 in the placebo group) completed the full three-month study. A significant reduction in the total days of illness was observed in the probiotic group (p-value=0.009). Additionally, the probiotic group exhibited a slightly lower frequency of GIT and RTI episodes compared to the placebo group (1.32 vs. 1.48, p-value=0.077). A trend towards fewer days with respiratory symptoms in the probiotic group was noted compared to the placebo group (6.12±2.19 vs. 7.56±3.65; p-value=0.0687), along with a non significant decline in the occurrence of RTIs at the 31-60 and 61-90 day periods. Similar declining trends were observed for the occurrence of GI infections and total days with GI symptoms between the two groups (0.24±0.88 vs. 0.53±1.2; p-value=0.4593). B. coagulans SNZ 1969® treatment was well-tolerated, and no severe adverse events were reported. Conclusion: The study demonstrated a significant reduction in the total days of illness with B. coagulans SNZ 1969® treatment compared to placebo. Additionally, B. coagulans SNZ 1969® treatment was found to be associated with a non significant decrease in the occurrence of GI and RTIs, as well as a relatively shorter duration of infection among malnourished children under five years of age.
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