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.

Study Overview

• Status: Completed
• Conditions: Immunity; Common Cold; Probiotic
• Intervention / Treatment: Dietary supplement: LP28 capsule; Dietary supplement: Placebo Capsule

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 407219
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 402202
    • National Chung Hsing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LP28 capsule; Subjects will take two capsule of the experimental group(LP28 capsule) within 30 minutes before breakfast and dinner each day.	Dietary supplement: LP28 capsule; LP28 capsule : 5.0×10^9 CFU/capsule
Placebo Comparator: Placebo capsule; Subjects will take two placebo capsule within 30 minutes before breakfast and dinner each day.	Dietary supplement: Placebo Capsule; Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WURSS-24	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).	From enrollment to the end of treatment at 12 weeks (measure daily)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune cell ratio	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.	From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
NK cell activity	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.	From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
Cytokines measurement	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.	From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
sIgA	Saliva samples were collected, and Secretory immunoglobulin A (sIgA) concentrations were analyzed using enzyme-linked immunosorbent assay (ELISA).	From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
α-amylase	Saliva samples were collected, and α-amylase concentrations were analyzed using enzyme-linked immunosorbent assay (ELISA).	From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
GSRS questionnaire	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.	From enrollment to the end of treatment at 12 weeks (measure weekly)
Defecation frequency and stool pattern	Defecation frequency was recorded, and stool characteristics, including shape, consistency, and color, were documented using the Bristol Stool Chart.	From enrollment to the end of treatment at 12 weeks (measure weekly)

Collaborators and Investigators

• Sponsor: Synbio Tech Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Actual): March 4, 2026
• Study Completion (Actual): May 14, 2026

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: SF24108C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No