A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of heat-treated Lactobacillus plantarum nF1 for immune functio
- Conditions
- Factors influencing health status and contact with health services
- Registration Number
- KCT0007927
- Lead Sponsor
- Immunobiotech
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1)Subject who voluntarily agrees to participate and signs in informed consent form
2)Healthy people, 20 = age < 70
3)Those who have had symptoms of upper respiratory tract infection (including colds) at least twice a year as of 2019, before the outbreak of COVID-19, and have had symptoms every year before that
4)White blood cell(WBC) ranged normal”
1)Patients who was diagnosed and are currently in the treatment of diabetes
2)Subjects who have taken antibiotics continuously within 2 months of the first visit or are likely to take them during the study period
3)Subjects who are currently in the treatment of significant clinical disease related to acute or chronic cardiovascular system, immune system, respiratory system, liver biliary, kidney and urinary tract, nervous system, musculoskeletal disorders, psychic, infection and blood neoplastic
4)6 Subjects who have medical history with myocardial infarction or cerebrovascular disease within 6 months
5)Subjects who have a neurologically or psychologically important medial history or who is currently suffering from a disease
6)Subjects who have uncontrolled high blood pressure.
7)Subjects whose AST or ALT exceeds 3 times of normal range
8)Subjects whose creatinine exceeds 2 times of normal range
9)Subjects who have complained of severe gastrointestinal symptoms such as heartburn, indigestion
10)Subjects who got a vaccination within 1 months before screening
11)Excessive smoker (more than 20 cigarettes/day)
12)Subjects who usually consume alcohol as follows
- men: 210g/week, women 140g/week
13)Subjects whose BMI is under 18.5 or exceeds 30.0
14)Subjects with low stress level (corresponding to ‘not at all’ or ‘somewhat’)
15)Subjects who have continuously consumed the following foods within 1 month of their first visit
- Dead bacteria of probiotics (lactic acid bacteria, etc.) or probiotics
- Probiotics (dietary fiber, fructooligosaccharide, etc.)
16)Subjects who have intaken or is intaking functional foods
17)Subjects who are planning to participate other studies within one month of their first visit
18)Subjects who are pregnant or breastfeeding or planning a pregnancy
19)Subjects who are sensitive to test foods/algae or have food allergies
20)Subjects who are deemed to be inappropriate to this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method K cell activity (%) et al.
- Secondary Outcome Measures
Name Time Method Adverse events et al.