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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010828
Enrollment
80
Registered
2025-07-29
Start date
2024-07-23
Completion date
Unknown
Last updated
2025-08-18

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 3x10³ and 8x10³ 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 undergoing pharmacological treatment for underlying diseases(e.g., hypertension, diabetes) 2) Subjects with uncontrolled hypertension(systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg, measured after 10 minutes of rest) 3) Subjects with uncontrolled diabetes(HbA1c > 7.0%) or those taking antidiabetic medications(oral hypoglycemic agents, insulin) 4) Subjects with TSH = 0.1 uIU/mL or = 10 uIU/mL 5) Subjects who received vaccination within the past 3 months(e.g., influenza, COVID-19, herpes zoster that may affect immune function) 6) Subjects who donated whole blood within the past 2 months or blood components within the past 4 weeks 7) Subjects with AST(GOT) or ALT(GPT) levels more than 3 times the normal range at the study site 8) Subjects with creatinine levels more than 1.5 times the normal range at the study site 9) Subjects who used steroids within the past 1 month 10) Subjects who took immunosuppressants, antacids, NSAIDs, or antihistamines within the past 1 month 11) Subjects who consumed functional foods or vitamins that may affect immune function within the past 2 weeks 12) Subjects who took antibiotics, intestinal regulators, probiotics, prebiotics, or regularly(= 4 times/week) consumed lactic acid bacteria products within the past 2 weeks 13) Subjects with severe gastrointestinal symptoms(e.g., heartburn, indigestion) 14) Subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period 15) Subjects who participated in another interventional clinical trial within the past 8 weeks, or who plan to participate in another interventional clinical trial during the study

Design outcomes

Primary

MeasureTime frame
NK Cell Activity(1.25:1, 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;Adverse Events;Clinical pathological examination (hematologic/hematochemical examination, urine test);Vital signs (blood pressure, pulse), body measurements (weight)

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: Feb 4, 2026