Common Cold, Immunity, Probiotic
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLP28 capsule
LP28 capsule : 5.0×10\^9 CFU/capsule
DIETARY_SUPPLEMENTPlacebo Capsule
Maltodextrin
Sponsors
Synbio Tech Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WURSS-24 | 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
| Measure | Time frame | Description |
|---|---|---|
| Immune cell ratio | 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. |
| NK cell activity | 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. |
| Cytokines measurement | 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. |
| sIgA | 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). |
| α-amylase | 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). |
| GSRS questionnaire | 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. |
| Defecation frequency and stool pattern | 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. |
Countries
Taiwan
Outcome results
None listed