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

February 19, 2026 updated by: Ho-Yeon Song, Soon Chun Hyang University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Busan, South Korea
        • Dong-A University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy male or female adults aged 19 to 75 years
  • Able to understand the study procedures and provide written informed consent
  • Willing to comply with the study protocol

Exclusion Criteria:

  • History of chronic or serious medical conditions that could interfere with study participation
  • Use of medications or supplements that may affect immune function within the screening period
  • Pregnant or breastfeeding women
  • Participation in another clinical study within 3 months prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Participants in this arm received heat-treated Lactiplantibacillus plantarum LM1004 once daily for 8 weeks.
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.
Placebo Comparator: Placebo Group
Participants in this arm received a placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Natural Killer (NK) Cell Activity
Time Frame: Baseline to Week 8
The primary outcome was the change in natural killer (NK) cell activity from baseline to the end of the intervention period.
Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Immune-related Biomarkers
Time Frame: Baseline to Week 8
Changes in immune-related biomarkers, including cytokines and white blood cell counts, from baseline to the end of the intervention period.
Baseline to Week 8
Change in Fatigue-related Questionnaire Scores
Time Frame: Baseline to Week 8
Changes in fatigue-related questionnaire scores from baseline to the end of the intervention period.
Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soon Chun Hyang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2023

Primary Completion (Actual)

November 13, 2023

Study Completion (Actual)

November 13, 2023

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM1004-IMMUNE-2024
  • DAUH-IRB-2023-08-24 (Other Identifier: Dong-A University Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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