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

NCT07433855 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Soon Chun Hyang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2023-11-13
Completion
2023-11-13

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07433855 on ClinicalTrials.gov