None listed
Conditions
Interventions
Dietary Supplement : Test Food (NPK-CBS):
- Stellar: Clostridium butyricum S-45-5 Probiotics
- Properties and Formulations: Brown oval tablets
- Usage and dosage: Consume once a day for 8 weeks, on
Sponsors
Soon Chun Hyang University Hospital Seoul
Gimpo Woori Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) adult men and women aged 19 and 70 and below 2) Those whose WBC Count values measured at visits 1 and 2 are greater than 3x103 cells/µL and less than 8x103 cells/µL 3) A person who meets at least one of the following criteria ? A person who has had at least two upper respiratory tract infections* within one year based on visit 1 *{Common Cold, Acute Tonsillitis, Acute Pharyngitis, Acute Laryngitis, Acute Rhinitis, etc.} ? A person who has had stomatitis at least once within one year as of visit 1 ? A person who has been infected with Herpes Zoster at least once within one year as of visit 1 ? A person who has had at least one uncomplicated cystitis within one year of visit 1 4) Those with a PSS (Stress Awareness Scale) score of 16 or higher in Visit 1 5) A person who has agreed to participate in this human body application test before the commencement of the human body application test and has completed a written consent form
Exclusion criteria
Exclusion criteria: 1) Persons currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary system, kidney and urinary system, nervous system, psychiatric, infectious disease and malignancy 2) a person currently undergoing treatment for an upper respiratory tract infection 3) A person who has a gastrointestinal disease (Cron's disease, etc.) that may affect the intake of food for human application testing, or who complains of severe gastrointestinal symptoms such as heartburn and indigestion 4) Persons with diseases that may affect the immune response, such as adult asthma, inflammatory systemic disease, autoimmune disease, metabolic syndrome, etc 5) Thyroid diseases such as thyroiditis, hyperthyroidism, and hypothyroidism (but thyroid nodules can participate) 6) A person who has undergone surgery within 6 months (180 days) based on visit 1 7) A person who has been infected with the COVID-19 virus within 3 months (90 days) based on Visit 1 8) A person who has been vaccinated (influenza, COVID-19 virus, shingles, etc.) that may affect immunity within three months (90 days) as of visit 1 9) A person who has used immunosuppressants, steroid drugs, nonsteroidal anti-inflammatory drugs, antihistamines, or antibiotics within one month (30 days) as of visit 1 10) A person who has used the following drugs (or foods) within two weeks of visitation 1 ? Health functional foods that can affect immunity (L-glutamine, lytic enzyme degradation extract, ginseng polysaccharide extract, shiitake mushroom mycelium AHCC, etc.) and vitamins ? a systemic antimicrobial agent ? Probiotics, prebiotics, and lactobacillus products taken continuously (more than 4 days a week) 11) Those with a BMI of less than 18.5 kg/m2 or more than 30 kg/m2 12) A person who has a history of drug and alcohol abuse/addiction, or is chronically consuming alcohol* *Drinking alcohol equivalent to an average of 40 g (280 g/week) per day for men and an average of 20 g/week for women (140 g/week) per day for women 13) Excessive smokers (20 or more per day) 14) Uncontrolled hypertension patients (systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg, and measurement criteria after stabilizing for 10 minutes for human body application test subjects) 15) Diabetes patients with HbA1c in excess of 7.0% or taking antidiabetic drugs (such as oral hypoglycemic agents, insulin, etc.) 16) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the agency's normal limit 17) A person with an eGFR of less than 60 mL/min/1.73 m2 18) A person within six months of giving birth based on visit 1 19) A person who has participated in other interventional clinical trials (including human-applied trials) within three months of the visit 1 or who plans to participate in other interventional clinical trials (including human-applied trials) during this human-applied trial period 20) A person who is pregnant or has a pregnancy plan during this human body application test, or a lactating woman 21) A person who is sensitive or allergic to food ingredients for this human application test 22) A person who judges that the tester is inappropriate for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NK Cell Activity(10:1, 5:1, 2.5:1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytokine(IFN-?, TNF-a, IL-6, IL-10, IL-12);WBC Count;incidence of upper respiratory tract infection, stomatitis, shingles, and simple cystitis;Adverse Events;Clinical pathological examination (hematologic/hematochemical examination, urine test);Vital Signs(Blood Pressure, Pulse, Temperature);Body Measurement (Weight);electrocardiogram | — |
Countries
Korea, Republic of
Contacts
Public ContactByung Wook Yoo
Soon Chun Hyang University Hospital Seoul
Outcome results
None listed