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A human study to evaluate of efficacy and safety of DEFENDUM® PROBIOTICS on immune function

A human study to evaluate of efficacy and safety of DEFENDUM® PROBIOTICS on immune function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010100
Enrollment
100
Registered
2024-12-30
Start date
2022-09-07
Completion date
Unknown
Last updated
2025-01-06

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 take placebo or DEFENDUM® PROBIOTICS once a day for 12 weeks.

Sponsors

Maeil Health Nutrition
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) Subject who had symptoms of upper respiratory tract infection more than twice a year before 2019

Exclusion criteria

Exclusion criteria: 1) White blood cell AND absolute neutrophil count exceed normal range. 2) Patients who was diagnosed and are currently in the treatment of diabetes 3) Those who have taken antibiotics within 2 months of the first visit or are likely to take it during the study 4) 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. 5) Subjects who have medical history with myocardial infarction or cerebrovascular disease within 6 months. 6) Subjects who have a neurologically or psychologically important medial history or who is currently suffering from a disease. 7) Subjects who have uncontrolled high blood pressure. 8) Subjects whose AST or ALT exceeds 3 times of normal range. 9) Subjects whose creatinine exceeds 2 times of normal range. 10) Subjects who have complained of severe gastrointestinal symptoms such as heartburn, indigestion. 11) Subjects who got a vaccination within 1 months before screening. 12) Excessive smoker 13) Subjects who usually consume alcohol as follows - men: 210g/week, women 140g/week 14) Subjects whose BMI is under 18.5 or exceeds 30.0 15) Subjects with a low level of stress 16) Subjects who continue to consume probiotics or prebiotics within one month of their first visit 17) Subjects who have intaken or is intaking functional foods 18) Subjects who are planning to participate other studies within one month of their first visit 19) Subjects who are pregnant or breastfeeding or planning a pregnancy. 20) Subjects who are sensitive to test foods/algae or have food allergies. 21) Subjects who are deemed to be inappropriate to this study.

Design outcomes

Primary

MeasureTime frame
NK cell activity (%)

Secondary

MeasureTime frame
Adverse event;bowel habit

Countries

Korea, Republic of

Contacts

Public ContactMinju Kim

Seoul Metropolitan Government Seoul National University Boramae Medical Center

dfnimj86@gmail.com+82-2-870-2682

Outcome results

None listed

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