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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LP28 capsule | Experimental | Subjects will take two capsule of the experimental group(LP28 capsule) within 30 minutes before breakfast and dinner each day. |
|
| Placebo capsule | Placebo Comparator | Subjects will take two placebo capsule within 30 minutes before breakfast and dinner each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP28 capsule | Dietary Supplement | LP28 capsule : 5.0×10^9 CFU/capsule |
| |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Chung Hsing University | Taichung | 402202 | Taiwan | |||
| Taichung Veterans General Hospital |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo Capsule |
| Dietary Supplement |
Maltodextrin |
|
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) |
| Taichung |
| 407219 |
| Taiwan |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |