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Completed

NCT Number: NCT06724185

Effects of LP28 on Immunity Enhancement in the Elderly

Due to the increasing attention on aging-related health issues, this study focuses on the elderly population as participants. The aim is to investigate whether supplementation with Lactobacillus plantarum LP28 can effectively enhance immunity, reduce the frequency and severity of common cold infections, and ultimately promote overall health in the elderly.

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Key information

Conditions

Common Cold Immunity Infections Picornaviridae Infections Probiotic RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Chung Hsing University, Taichung, Taiwan

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Those who had symptoms of common cold or tonsillitis at least twice in the past year.

Exclusion criteria

  • People who have liver, kidney, immune, or neoplastic diseases diagnosed by doctor.
  • People with mental illnesses such as schizophrenia or depression.
  • People who have allergic rhinitis.
  • People who have a current condition of drug or alcohol dependence.
  • Any person is deemed inappropriate by the researcher for the clinical trial.

Treatment and study plan

LP28 capsule

Dietary Supplement

LP28 capsule : 5.0×10^9 CFU/capsule

placebo capsule

Dietary Supplement

Maltodextrin

Primary outcomes

  1. WURSS-24

    Time frame: From enrollment to the end of treatment at 12 weeks (measure daily)

    The WURSS-24 (Wisconsin Upper Respiratory Symptom Survey-24) is a questionnaire designed to assess the impact of upper respiratory tract infections, such as the common cold, on daily life and health. It includes 24 questions covering symptoms (e.g., cough, runny nose, fatigue) and how they affect daily activities, work, and social interactions. Patients rate each item on a scale from 0 (no problem) to 7 (severe problem).

Secondary outcomes

  1. Immune cell ratio

    Time frame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)

    Blood samples were collected, and the proportions of immune cells were analyzed using flow cytometry, including: (1) CD3+/lymphocyte, (2) CD4+/CD3+, (3) CD8+/CD3+, and (4) CD56+CD16+/lymphocyte.

  2. NK cell activity

    Time frame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)

    Peripheral blood mononuclear cells (PBMCs) were isolated, and magnetic bead-based separation was used to deplete non-NK cells. The K562 human immortalized myelogenous leukemia cell line was then used as target cells, and the proportion of K562 cells lysed by NK cells was measured as an indicator of NK cell activity.

  3. Cytokines measurement

    Time frame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)

    Plasma was collected, and cytokine concentrations were analyzed using enzyme-linked immunosorbent assay (ELISA). The detection items included IL-4, IL-6, IL-12, IFN-γ, CRP and TNF-α.

  4. sIgA

    Time frame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)

    Saliva samples were collected, and Secretory immunoglobulin A (sIgA) concentrations were analyzed using enzyme-linked immunosorbent assay (ELISA).

  5. α-amylase

    Time frame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)

    Saliva samples were collected, and α-amylase concentrations were analyzed using enzyme-linked immunosorbent assay (ELISA).

  6. GSRS questionnaire

    Time frame: From enrollment to the end of treatment at 12 weeks (measure weekly)

    The Gastrointestinal Symptom Rating Scale (GSRS) is a questionnaire used to evaluate the severity of gastrointestinal symptoms. It includes questions on five key areas: abdominal pain, reflux, diarrhea, indigestion, and constipation. Patients rate their symptoms on a 7-point Likert scale, where higher scores indicate more severe symptoms.

  7. Defecation frequency and stool pattern

    Time frame: From enrollment to the end of treatment at 12 weeks (measure weekly)

    Defecation frequency was recorded, and stool characteristics, including shape, consistency, and color, were documented using the Bristol Stool Chart.

Sponsors and collaborators

Lead sponsor

Synbio Tech Inc.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
May 28, 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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