None listed
Conditions
Interventions
Dietary Supplement : Treatment Group: Participants will take one capsule of L. rhamnosus LM1019 daily for 8 weeks.
Control Group: Participants will take one capsule of a placebo daily for 8 weeks.
Sponsors
Lactomason
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals aged 19 to 75 years. 2. Individuals whose peripheral blood white blood cell count measured at Visit 1 is between 3,000 cells/µL and 8,000 cells/µL. 3. Individuals who meet at least one of the following criteria: ? Individuals who had two or more upper respiratory infections within one year prior to Visit 1. ? Individuals who had two or more cases of stomatitis within one year prior to Visit 1. ? Individuals who had a herpes zoster infection within one year prior to Visit 1. ? Individuals who had three or more cases of uncomplicated cystitis within one year prior to Visit 1, or two or more cases of uncomplicated cystitis within six months prior to Visit 1. 4. Individuals with a Perceived Stress Scale (PSS) score of 16 or higher. 5. Individuals who have agreed to participate in this human application test before its commencement and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Individuals currently undergoing medication treatment due to underlying diseases. 2) Individuals with hypertension, defined as a systolic blood pressure of 140 mmHg or higher, or a diastolic blood pressure of 90 mmHg or higher. 3) Individuals with a fasting blood glucose level of 126 mg/dL or higher, or those with diabetes. 4) Individuals with a TSH level of 0.1 uIU/mL or lower, or 10 uIU/mL or higher. 5) Individuals who have received a vaccination within 3 months prior to Visit 1. 6) Individuals who were confirmed to have COVID-19 within 6 weeks prior to Visit 1. 7) Individuals with asthma, rhinitis, or autoimmune diseases. 8) Individuals with AST (GOT) or ALT (GPT) levels exceeding 3 times the upper normal limit. 9) Individuals with creatinine levels exceeding 1.5 times the upper normal limit. 10) Individuals who have taken steroids, antibiotics, immunosuppressants, or acid suppressants within 1 month prior to Visit 1. 11) Individuals who have consumed health supplements or vitamins that may affect immunity within 2 weeks prior to Visit 1. 12) Individuals who have taken or consumed digestive aids, probiotics, prebiotics, or consistently consumed lactobacillus products and fermented milk more than 4 times a week within 2 weeks prior to Visit 1. 13) Individuals who suffer from severe gastrointestinal symptoms such as heartburn or indigestion. 14) Pregnant or breastfeeding women, or women planning to become pregnant during the study period, and those who do not agree to use appropriate contraception. 15) Individuals who have participated in another interventional clinical trial within 8 weeks prior to Visit 1, or plan to participate in another interventional clinical trial during this study period. 16) Individuals with a history of hypersensitivity to the ingredients of the study drug or food (e.g., lactobacillus), or clinically significant hypersensitivity. 17) Individuals with a BMI (Body Mass Index) of 30 or higher. 18) Individuals who have consumed excessive alcohol within 1 month (30 days) prior to Visit 1 (men >210 g/week, women >140 g/week). 19) Individuals deemed unsuitable by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NK cell activity | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytokines;WBC count;The frequency of upper respiratory tract infections.;Fatigue Severity Scale (FSS);Self-assessment of post-intervention improvement by the subject | — |
Countries
Korea, Republic of
Contacts
Public ContactChae Min Baeg
Global Medical Research Center
Outcome results
None listed