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An 8-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Lactobacillus paracasei HY7017 in enhancing immune function

An 8-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Lactobacillus paracasei HY7017 in enhancing immune function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0012349
Enrollment
120
Registered
2026-07-28
Start date
2022-07-27
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

None listed

Interventions

Sponsors

Vievis Namuh Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects aged 19 to 75 years 2) Subjects with a peripheral white blood cell count between 3x10^3 and 8x10^3 cells/µL at Visit 1 3) Subjects who meet at least one of the following criteria: ? Two or more episodes of upper respiratory tract infections within the past year (e.g., common cold, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis) ? Two or more episodes of stomatitis within the past year ? History of herpes zoster infection within the past year ? Three or more episodes of uncomplicated cystitis within the past year, or two or more episodes within the past six months 4) Subjects who voluntarily provide written informed consent prior to participation

Exclusion criteria

Exclusion criteria: 1) Subjects currently receiving pharmacological treatment for underlying diseases such as hypertension or diabetes. 2) Subjects with hypertension (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measured after 10 minutes of rest at Visit 1). 3) Subjects with fasting blood glucose of 126 mg/dL or higher, or subjects with diabetes mellitus receiving antidiabetic medications such as oral hypoglycemic agents or insulin. 4) Subjects with TSH levels of 0.1 uIU/mL or less, or 10 uIU/mL or higher. 5) Subjects who received vaccination within 3 months prior to Visit 1, including influenza, COVID-19, or herpes zoster vaccines that may affect immune function. 6) Subjects who donated whole blood within 2 months prior to Visit 1 or blood components within 4 weeks prior to Visit 1. 7) Subjects with AST (GOT) or ALT (GPT) levels of at least 3 times the upper limit of normal at the study site. 8) Subjects with creatinine levels of at least 1.5 times the upper limit of normal at the study site. 9) Subjects who used steroids within 1 month prior to Visit 1. 10) Subjects who received immunosuppressants, acid suppressants, nonsteroidal anti-inflammatory drugs, or antihistamines within 1 month prior to Visit 1. 11) Subjects who consumed health functional foods or vitamins that may affect immune function within 2 weeks prior to Visit 1. 12) Subjects who took antibiotics, intestinal regulators, probiotics, or continuously consumed lactic acid bacteria products at least 4 times per week within 2 weeks prior to Visit 1. 13) Subjects complaining of severe gastrointestinal symptoms such as heartburn or indigestion. 14) Subjects who are pregnant, breastfeeding, or planning to become pregnant during the course of the clinical trial. 15) Subjects who participated in another interventional clinical trial, including human application studies, within 8 weeks prior to Visit 1, or who plan to participate in another interventional clinical trial, including human application studies, after the start of this clinical trial. 16) Subjects who are sensitive or allergic to any ingredient of the investigational product used in this clinical trial. 17) Subjects who consumed excessive alcohol within 1 month prior to Visit 1 (men > 210 g/week, women > 140 g/week). 18) Subjects whom the investigator deems unsuitable for any other reason.

Design outcomes

Primary

MeasureTime frame
NK Cell Activity(1:1, 5:1, 10:1)

Secondary

MeasureTime frame
Cytokine(IFN ? , TNF a , IL 2, IL 4, IL 6, IL 10, IL 12, IgG);WBC Count;Frequency of upper respiratory tract infections, stomatitis, herpes zoster, and uncomplicated cystitis;Assessment of improvement in study subjects in a human application trial

Countries

Korea, Republic of

Contacts

Public ContactSoo-Young Choi

Vievis Namuh Hospital

ivdmdd@vievisnamuh.com+82-2-519-8947

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Aug 10, 2026