Common ColdNCT06724185
Effects of LP28 on Immunity Enhancement in the Elderly
A study testing LP28 capsule in people with Common Cold and Immunity, run by Synbio Tech Inc. at 2 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold, Immunity, Probiotic
- What is being tested?
- LP28 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 2 sitesTaiwan
- Study dates
- 9 Jul 2024to 14 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who had symptoms of common cold or tonsillitis at least twice in the past year.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Chung Hsing University
Taichung, 402202
Taichung Veterans General Hospital
Taichung, 407219
About this study
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.
- Conditions
- Common Cold, Immunity, Probiotic
- Being tested
- LP28 capsule, Placebo Capsule
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP28 capsuleDietary supplement
LP28 capsule : 5.0×10^9 CFU/capsule
Placebo CapsuleDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| LP28 capsule | Experimental | Subjects will take two capsule of the experimental group(LP28 capsule) within 30 minutes before breakfast and dinner each day. Receives: Dietary Supplement: LP28 capsule |
| Placebo capsule | Placebo comparator | Subjects will take two placebo capsule within 30 minutes before breakfast and dinner each day. Receives: Dietary Supplement: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 12 weeks (measure daily)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks (measure weekly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start9 Jul 2024
- Primary completion4 Mar 2026
- Study completion14 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synbio Tech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724185
- Sponsor's protocol ID
- SF24108C
- Status last verified
- May 2026
- First submitted
- 4 Dec 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of LP28 on Immunity Enhancement in the Elderly
- ClinicalTrials.gov ID
- NCT06724185
- Acronym / sponsor ID
- SF24108C
- Conditions
- Common Cold, Immunity, Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Synbio Tech Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LP28 capsule | Experimental | Dietary Supplement: LP28 capsuleSubjects will take two capsule of the experimental group(LP28 capsule) within 30 minutes before breakfast and dinner each day. |
| Placebo capsule | Placebo comparator | Dietary Supplement: Placebo CapsuleSubjects will take two placebo capsule within 30 minutes before breakfast and dinner each day. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those who had symptoms of common cold or tonsillitis at least twice in the past year.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP28 capsuleLP28 capsule : 5.0×10^9 CFU/capsule | Dietary supplement | LP28 capsule |
| Placebo CapsuleMaltodextrin | Dietary supplement | Placebo capsule |
Primary outcome
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).
7 secondary outcomes
Immune cell ratio
Time frame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
NK cell activity
Time frame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
Cytokines measurement
Time frame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
sIgA
Time frame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
α-amylase
Time frame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
GSRS questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks (measure weekly)
Defecation frequency and stool pattern
Time frame: From enrollment to the end of treatment at 12 weeks (measure weekly)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LP28 capsule in people with Common Cold and Immunity, run by Synbio Tech Inc. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WURSS-24 (time frame: From enrollment to the end of treatment at 12 weeks (measure daily)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.