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A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of heat-treated Lactobacillus plantarum nF1 for immune function

A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of heat-treated Lactobacillus plantarum nF1 for immune function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007927
Enrollment
100
Registered
2022-11-22
Start date
2022-11-11
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Subjects will be randomly allocated to placebo or experimental group and take 1 capsule per day for 8 weeks

Sponsors

Immunobiotech
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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”

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
NK cell activity (%) et al.

Secondary

MeasureTime frame
Adverse events et al.

Countries

Korea, Republic of

Contacts

Public ContactChaemin Baeg

Global Medical Research Center

chamin38@gmail.com+82-2-517-0877

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026