NCT07433855

Efficacy and Safety of Heat-Treated Lactiplantibacillus Plantarum LM1004 on Immune Function

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Heat-Treated Lactiplantibacillus Plantarum LM1004 on Immune Function in Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Soon Chun Hyang University · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study was conducted to evaluate the efficacy and safety of heat-treated Lactiplantibacillus plantarum LM1004 in improving immune function in adults. This was a randomized, double-blind, placebo-controlled, single-center clinical trial. Healthy adults aged 19 to 75 years who met the eligibility criteria were enrolled and randomly assigned to receive either the study product or a placebo. Participants in the study group received heat-treated Lactiplantibacillus plantarum LM1004, while participants in the control group received a placebo. The study product or placebo was taken once daily for 8 weeks. The primary outcome of the study was the change in natural killer (NK) cell activity from baseline. Secondary outcomes included changes in immune-related biomarkers, such as cytokines, white blood cell counts, total IgE levels, and fatigue-related questionnaire scores. Safety was evaluated by monitoring adverse events, vital signs, and laboratory test results throughout the study period. The results of this study were intended to determine whether daily intake of heat-treated Lactiplantibacillus plantarum LM1004 is safe and may help improve immune function in adults.

Conditions

• Immune Function

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Heat-treated Lactiplantibacillus plantarum LM1004	Heat-treated Lactiplantibacillus plantarum LM1004 was administered orally as a capsule at a dose of 500 mg once daily for 8 weeks.
DIETARY_SUPPLEMENT	Dietary Supplement	The placebo was administered orally as a capsule identical in appearance to the study product, once daily for 8 weeks.

Timeline

• Start date: 2023-08-31
• Primary completion: 2023-11-13
• Completion: 2023-11-13
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: South Korea