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Completed

NCT Number: NCT07433855

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

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.

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Key information

Conditions

Immune Function

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dong-A University Hospital

Busan, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heat-treated Lactiplantibacillus plantarum LM1004

Dietary Supplement

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Soon Chun Hyang University

Other

Registry information

Official study title

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

Acronym: LM1004-IMMUNE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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