KCT0012349进行中（未招募）不适用
An 8-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Lactobacillus paracasei HY7017 in enhancing immune function
Vievis Namuh Hospital0 个研究点目标入组 120 人开始时间: 2022年7月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •Subjects aged 19 to 75 years
- •Subjects with a peripheral white blood cell count between 3x10^3 and 8x10^3 cells/µL at Visit 1
- •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
- •Subjects who voluntarily provide written informed consent prior to participation
排除标准
- •Subjects currently receiving pharmacological treatment for underlying diseases such as hypertension or diabetes.
- •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).
- •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.
- •Subjects with TSH levels of 0.1 uIU/mL or less, or 10 uIU/mL or higher.
- •Subjects who received vaccination within 3 months prior to Visit 1, including influenza, COVID-19, or herpes zoster vaccines that may affect immune function.
- •Subjects who donated whole blood within 2 months prior to Visit 1 or blood components within 4 weeks prior to Visit
- •Subjects with AST (GOT) or ALT (GPT) levels of at least 3 times the upper limit of normal at the study site.
- •Subjects with creatinine levels of at least 1.5 times the upper limit of normal at the study site.
- •Subjects who used steroids within 1 month prior to Visit
- •Subjects who received immunosuppressants, acid suppressants, nonsteroidal anti-inflammatory drugs, or antihistamines within 1 month prior to Visit
- •Subjects who consumed health functional foods or vitamins that may affect immune function within 2 weeks prior to Visit
- •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
- •Subjects complaining of severe gastrointestinal symptoms such as heartburn or indigestion.
- •Subjects who are pregnant, breastfeeding, or planning to become pregnant during the course of the clinical trial.
- •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.
- •Subjects who are sensitive or allergic to any ingredient of the investigational product used in this clinical trial.
- •Subjects who consumed excessive alcohol within 1 month prior to Visit 1 (men > 210 g/week, women > 140 g/week).
- •Subjects whom the investigator deems unsuitable for any other reason.
研究组 & 干预措施
Dietary Supplement : Participants who voluntarily sign the informed consent form and are suspected of having weakened immunity due to frequent infections—with normal or slightly reduced white blood cell counts—will undergo screening through an on-site evaluation to determine their eligibility based on the inclusion and exclusion criteria.
干预措施: Dietary Supplement : Participants who voluntarily sign the informed consent form and are suspected of having weakened immunity due to frequent infections—with normal or slightly reduced white blood cell counts—will undergo screening through an on-site evaluation to determine their eligibility based on the inclusion and exclusion criteria.
研究者
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