Immune FunctionNCT03209635
Weissella Cibaria JW15 Consumption and NK Cell Activity
A study testing Probiotic in people with Immune Function, run by Yonsei University.
Trial summary
A The aim of this study was to investigate the impact of consuming Weissella cibaria (W. cibaria) JW15 supplementation isolated from Kimchi, Korea traditional fermented food, on natural killer (NK) cell activity and circulating levels of cytokines and immunoglobulin (Ig). Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Function
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 20 Mar 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nondiabetic (fasting serum glucose concentration < 126 mg/dL)
- Subjects with 4,000-8,000 leukocyte counts
Who cannot join
- Constant consumption of any probiotic products
- Taking medicine related to inflammation within one month before screening
- Allergy to probiotics
- Lactose intolerance
- Diabetes
- History/presence of significant metabolic disease
- Acute or chronic disease requiring treatment
- Taking any medications
About this study
A The aim of this study was to investigate the impact of consuming Weissella cibaria (W. cibaria) JW15 supplementation isolated from Kimchi, Korea traditional fermented food, on natural killer (NK) cell activity and circulating levels of cytokines and immunoglobulin (Ig).
Read the detailed description
A randomized, double-blinded, placebo-controlled study was conducted on 100 nondiabetic subjects. Over an eight-week testing period, the probiotic group consumed 4 capsules (300 mg/capsule) containing 1 x 10^10 colony-forming units (cfu) of W. cibaria JW15 each day, whereas the placebo group consumed the same product without a probiotic.
- Conditions
- Immune Function
- Being tested
- Placebo, Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
4 capsules (300 mg/capsule) containing 52% crystalline cellulose and 46% lactose in identical-looking with test product
ProbioticDietary supplement
4 capsules (300 mg/capsule) containing each capsule 1.0 x 10^10 colony-forming units (cfu) of Weissella cibaria JW15, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 4 capsules (300 mg/capsule) containing 52% crystalline cellulose and 46% lactose in identical-looking with test product Receives: Dietary Supplement: Placebo |
| Probiotic | Experimental | 4 capsules (300 mg/capsule) containing each capsule 1.0 x 10^10 colony-forming units (cfu) of Weissella cibaria JW15, twice a day Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural killer cell activity at baseline
Natural killer cell activity (%)
Measured: Baseline
Natural killer cell activity at 8-week follow up
Natural killer cell activity (%)
Measured: 8-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Apr 2016
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune FunctionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Lee, Yonsei University
- Investigators
- Jong Ho Lee, Ph.D., Principal investigator, Dept. of Food and Nutrition, Colleage of Human Ecology, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209635
- Sponsor's protocol ID
- AI_probiotic_NK
- Status last verified
- Jul 2017
- First submitted
- 4 Jul 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weissella Cibaria JW15 Consumption and NK Cell Activity
- ClinicalTrials.gov ID
- NCT03209635
- Acronym / sponsor ID
- AI_probiotic_NK
- Conditions
- Immune Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 6 Jul 2017 (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.
A The aim of this study was to investigate the impact of consuming Weissella cibaria (W. cibaria) JW15 supplementation isolated from Kimchi, Korea traditional fermented food, on natural killer (NK) cell activity and circulating levels of cytokines and immunoglobulin (Ig).
Detailed description
A randomized, double-blinded, placebo-controlled study was conducted on 100 nondiabetic subjects. Over an eight-week testing period, the probiotic group consumed 4 capsules (300 mg/capsule) containing 1 x 10^10 colony-forming units (cfu) of W. cibaria JW15 each day, whereas the placebo group consumed the same product without a probiotic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo4 capsules (300 mg/capsule) containing 52% crystalline cellulose and 46% lactose in identical-looking with test product |
| Probiotic | Experimental | Dietary Supplement: Probiotic4 capsules (300 mg/capsule) containing each capsule 1.0 x 10^10 colony-forming units (cfu) of Weissella cibaria JW15, twice a day |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nondiabetic (fasting serum glucose concentration < 126 mg/dL)
- Subjects with 4,000-8,000 leukocyte counts
Key exclusion criteria (8 listed)
- Constant consumption of any probiotic products
- Taking medicine related to inflammation within one month before screening
- Allergy to probiotics
- Lactose intolerance
- Diabetes
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 |
|---|---|---|
| Placebo4 capsules (300 mg/capsule) containing 52% crystalline cellulose and 46% lactose in identical-looking with test product | Dietary supplement | Placebo |
| Probiotic4 capsules (300 mg/capsule) containing each capsule 1.0 x 10^10 colony-forming units (cfu) of Weissella cibaria JW15, twice a day | Dietary supplement | Probiotic |
Primary outcome
Natural killer cell activity at baseline
Time frame: Baseline
Natural killer cell activity (%)
Natural killer cell activity at 8-week follow up
Time frame: 8-week follow up
Natural killer cell activity (%)
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 6 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Jong Ho Lee, Ph.D. principal investigator
Dept. of Food and Nutrition, Colleage of Human Ecology, Yonsei University
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Immune Function, run by Yonsei University.
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 2 inclusion and 8 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Natural killer cell activity at baseline (time frame: Baseline). The study lists 2 primary outcomes in all. 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 6 Jul 2017; AzTrials last refreshed its copy on 3 Nov 2026.