Safety evaluation of the long-term intake of heat-killed Lactobacillus helveticus MCC1848 in healthy adults: a randomized, double-blind, placebo-controlled study

BACKGROUND: Heat-killed Lactobacillus helveticus MCC1848 is a postbiotic, which potentially aids in maintaining a positive mood. Daily intake of heat-killed L. helveticus MCC1848 for 4 weeks by healthy adults is known to be safe. However, the safety of long-term L. helveticus MCC1848 intake has not been investigated. METHODS: This study aimed to evaluate the safety of long-term intake of 25 billion heat-killed L. helveticus MCC1848 in healthy adults through a randomized controlled trial involving 40 participants. The study participants were randomly assigned to either the MCC1848 group (n = 20) or placebo group (n = 20). During a 12-week period, the MCC1848 group received the test powder containing 25 billion cells of heat-killed L. helveticus MCC1848, which is five times the minimum effective dose suggested for maintaining a positive mood. The placebo group received dextrin powder without any detectable heat-killed L. helveticus MCC1848. Safety evaluations included anthropometric and blood pressure measurements, hematological and biochemical tests, urinalysis, and adverse event monitoring. RESULTS: No clinical issues were observed in either of the biochemical evaluations. Furthermore, no adverse events were reported due to the intake of heat-killed L. helveticus MCC1848. CONCLUSIONS: The results of this study suggest that 25 billion heat-killed L. helveticus MCC1848 for 12 weeks is safe for intake in healthy adults. TRIAL REGISTRATION: The clinical trial was registered as UMIN000055233 (Registration Date: August 13, 2024) in the Clinical Trials Registry of the University Hospital Medical Information Network.

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