Respiratory SymptomsNCT05544942
GCWB1001 Evaluates the Effectiveness and Safety of Respiratory Health
A study testing Lactobacillus plantarum and maltodextrin in people with Respiratory Symptoms, run by Green Cross Wellbeing at 4 sites in South Korea.
Trial summary
This human application test was designed to evaluate the effectiveness and safety of the losing suction tendon, compared to the control food when the GCWB1001 was consistent with the symptoms of the respiratory symptoms of mildness. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Respiratory Symptoms
- What is being tested?
- Lactobacillus plantarum and maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 23 Aug 2022to 31 Aug 2023
- 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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the time of screening, 19 or 70 years
- Those who have two or more symptoms of cough, sputum, lake striking or chest stuffy for more than one month, and BCSS at 3 or more
- Those with FEV 1 /FVC 70 or higher
- Those who agreed to participation in this human application test before the beginning of the human test and signed in the Informed Consent Form
Who cannot join
- Severe cardiovascular, immune system, gastrointestinal and biliary meters, kidney and urinary systems, Those who are currently treated with neurological system, musculoskeletal system, mental, infectious diseases and malignant tumors
- Those who have clinically significant respiratory diseases findings as a result of chest X-ray shooting
- Those who have been diagnosed with chronic obstructive pulmonary disease (COPD) or asthma
- Chronic bronchitis (BCSS 9 or more points or more Those who have continuous cough, sputum symptoms for more than 3 months)
- A person who has a respiratory symptom due to virus or bacteria within 4 weeks of visit (Influenza, Corona Virus infection 19, pneumonia, acute infection, etc.) However, if the corona virus infection 19 has worsened or new symptoms of respiratory symptoms occur (However, if there are no additional respiratory symptoms caused by corona-19 infections, you can participate after 4 weeks after isolation. In the case of additional respiratory symptoms, the symptoms improve and can be participated if they have been restored to the time of recovery so that there is no difference compared to before infection.)
- Those who take drugs for the purpose of taking immunosuppressive agents, or for the purpose of regulating Jinhae expectoration within 4 weeks of visit.
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- Those who take health functional foods related to improvement of respiratory health within 2 weeks of visit 1
- Those who administered antibiotics within 2 weeks of visiting 1
- Probiotics and those who consistently consume lactic acid bacteria products (4 or more times a week) within 2 weeks
- Those who are less than 6 months after smokers or smoking cessation
- Less than 4 weeks of visit, a person who falls under alcohol with an average of 30 g (210 shares) per day (210 weeks), an average of 20 g or more (140 shares) per day (140 shares)
- Those who are more than twice the summit of Creatinine.
- AST (G OT) or ALT (GPT) is three times more than the normal upper limit of the embodiment
- Inconsidable high blood pressure patients systolic blood pressure 160 mmHg or higher or relaxation blood pressure 100 mmHg or higher, test target 10 minutes stabilization
- Ungodined diabetic patient empathy 180 mg/dL or more
- Those who are pregnant or have a planning plan for lactation or this human application period
- Those who have been administered to include other arbitral clinical trial applications within 3 months of visitor and have received food for adoption of drugs for clinical trials. Those who plan to participate
- Those who are sensitive or allergic to food ingredients for this human application
- Those who judge that the tester is inadequate for other reasons
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
HALLYM UNIV. Chuncheon MEDICAL CENTER
Chuncheon
Hallym Univ. Medical Center
Gyeonggi-do
Chungbuk national university hospital
Jungbuk
Hanyang University Seoul Hospital
Seoul
About this study
Official title: GCWB1001 12 Weeks, Multi -Tube, Randomized Assignment, Double -Eye, Placebo Control Human Application Test for Evaluating the Effectiveness and Safety of the Respiratory Health Health
This human application test was designed to evaluate the effectiveness and safety of the losing suction tendon, compared to the control food when the GCWB1001 was consistent with the symptoms of the respiratory symptoms of mildness.
- Conditions
- Respiratory Symptoms
- Being tested
- Lactobacillus plantarum, maltodextrin
- Medical subject headings
- Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarumDietary supplement
1 capsule once a day
maltodextrinOther
1 capsule once a day
| Study group | Role | What they receive |
|---|---|---|
| GCWB1001 | Experimental | 1 capsule once a day Receives: Dietary Supplement: Lactobacillus plantarum |
| Placebo | Active comparator | 1 capsule once a day Receives: Other: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change amoust of BCSS
The comparison of the bcss change in the before and after the intake of the BCSS is analyzed using the Paired T-TEST, and the degree of change between the test group and the control group at each point of view is the Two Sample T-Test and the Wilcoxon Rank Sum test It is conducted to evaluate whether there is a significant difference.
Measured: week -2, 6 and 12
Secondary outcomes (4)
Change amoust of Lung function (FVC, FEV1, FEV1/FVC)
The comparison of the Lung function (FVC, FEV1, FEV1/FVC) change in the before and after the intake of the Lung function (FVC, FEV1, FEV1/FVC) is analyzed using the Paired T-TEST, and the degree of change between the test group and the control group at each point of view is the Two Sample T-Test and the Wilcoxon Rank Sum test It is conducted to evaluate whether there is a significant difference.
Measured: week -2, 6 and 12
Change amoust of SGRQ
The comparison of the SGRQ change in the before and after the intake of the SGRQ is analyzed using the Paired T-TEST, and the degree of change between the test group and the control group at each point of view is the Two Sample T-Test and the Wilcoxon Rank Sum test It is conducted to evaluate whether there is a significant difference.
Measured: week -2, 6 and 12
Change amoust of VAS
The comparison of the VAS change in the before and after the intake of the VAS is analyzed using the Paired T-TEST, and the degree of change between the test group and the control group at each point of view is the Two Sample T-Test and the Wilcoxon Rank Sum test It is conducted to evaluate whether there is a significant difference.
Measured: week -2, 6 and 12
Change amoust of blood biomarker (TNF-α, IgE, IL-6, IL-10, IFN-γ)
The comparison of the blood biomarker change in the before and after the intake of the blood biomarker is analyzed using the Paired T-TEST, and the degree of change between the test group and the control group at each point of view is the Two Sample T-Test and the Wilcoxon Rank Sum test It is conducted to evaluate whether there is a significant difference.
Measured: week -2 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start23 Aug 2022
- Primary completion30 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory SymptomsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Wellbeing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544942
- Sponsor's protocol ID
- GCWB109
- Status last verified
- Feb 2026
- First submitted
- 5 Sep 2022
- Last updated
- 23 Feb 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GCWB1001 12 Weeks, Multi -Tube, Randomized Assignment, Double -Eye, Placebo Control Human Application Test for Evaluating the Effectiveness and Safety of the Respiratory Health Health
- ClinicalTrials.gov ID
- NCT05544942
- Acronym / sponsor ID
- GCWB109
- Conditions
- Respiratory Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Green Cross WellbeingIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 19 Sep 2022 (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.
This human application test was designed to evaluate the effectiveness and safety of the losing suction tendon, compared to the control food when the GCWB1001 was consistent with the symptoms of the respiratory symptoms of mildness.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GCWB1001 | Experimental | Dietary Supplement: Lactobacillus plantarum1 capsule once a day |
| Placebo | Active comparator | Other: maltodextrin1 capsule once a day |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At the time of screening, 19 or 70 years
- Those who have two or more symptoms of cough, sputum, lake striking or chest stuffy for more than one month, and BCSS at 3 or more
- Those with FEV 1 /FVC 70 or higher
- Those who agreed to participation in this human application test before the beginning of the human test and signed in the Informed Consent Form
Key exclusion criteria (19 listed)
- Severe cardiovascular, immune system, gastrointestinal and biliary meters, kidney and urinary systems, Those who are currently treated with neurological system, musculoskeletal system, mental, infectious diseases and malignant tumors
- Those who have clinically significant respiratory diseases findings as a result of chest X-ray shooting
- Those who have been diagnosed with chronic obstructive pulmonary disease (COPD) or asthma
- Chronic bronchitis (BCSS 9 or more points or more Those who have continuous cough, sputum symptoms for more than 3 months)
- A person who has a respiratory symptom due to virus or bacteria within 4 weeks of visit (Influenza, Corona Virus infection 19, pneumonia, acute infection, etc.) However, if the corona virus infection 19 has worsened or new symptoms of respiratory symptoms occur (However, if there are no additional respiratory symptoms caused by corona-19 infections, you can participate after 4 weeks after isolation. In the case of additional respiratory symptoms, the symptoms improve and can be participated if they have been restored to the time of recovery so that there is no difference compared to before infection.)
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 |
|---|---|---|
| Lactobacillus plantarum1 capsule once a day | Dietary supplement | GCWB1001 |
| maltodextrin1 capsule once a day | Other | Placebo |
Primary outcome
Change amoust of BCSS
Time frame: week -2, 6 and 12
The comparison of the bcss change in the before and after the intake of the BCSS is analyzed using the Paired T-TEST, and the degree of change between the test group and the control group at each point of view is the Two Sample T-Test and the Wilcoxon Rank Sum test It is conducted to evaluate whether there is a significant difference.
4 secondary outcomes
Change amoust of Lung function (FVC, FEV1, FEV1/FVC)
Time frame: week -2, 6 and 12
Change amoust of SGRQ
Time frame: week -2, 6 and 12
Change amoust of VAS
Time frame: week -2, 6 and 12
Change amoust of blood biomarker (TNF-α, IgE, IL-6, IL-10, IFN-γ)
Time frame: week -2 and 12
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 23 Feb 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum and maltodextrin in people with Respiratory Symptoms, run by Green Cross Wellbeing at 4 sites in South Korea.
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 4 inclusion and 19 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 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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. 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?
Change amoust of BCSS (time frame: week -2, 6 and 12). 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 23 Feb 2026.