NCT06827327已完成3 期
A Randomized Controlled Trial Evaluating the Efficacy of Lactococcus Lactis JCM 5805 (LC-Plasma) Lactic Acid Bacteria in Preventing Upper Respiratory Tract Infections and Reducing Symptom Severity and Duration
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 637
- 试验地点
- 1
- 主要终点
- Cumulative incidence number of URTIs
研究概览
简要总结
The goal of this study is to evaluate the efficacy of the LC-Plasma in preventing upper respiratory tract infections (URTIs) in healthy volunteers. Researchers will compare LC-Plasma to placebo to see if LC-Plasma prevents URTIs. Participants will take a tablet containing LC-Plasma or placebo daily for 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-60 years living in Australia
- •Individuals with a history of recurrent upper respiratory tract infections
- •Able to provide informed consent
- •Generally healthy
- •Agree to not participate in another clinical trial while enrolled in this trial
- •Agree to maintain their usual daily activities without significant changes. This includes not changing their current diet or stopping/starting a new exercise regimen during entire study period
- •Agree not to travel internationally for over 1 month in a single trip during the intervention period (baseline to study completion).
- •Females of childbearing potential must a prescribed form of birth control
排除标准
- •Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, neurological disorders such as multiple sclerosis.
- •Unstable illness e.g., changing medication/treatment.
- •BMI <18.5, >30
- •Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
- •Individuals with chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease).
- •Has current symptoms of an acute sickness.
- •Active smokers, nicotine use or drug (prescription or illegal substances) abuse
- •Current alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients in the active or placebo formula
- •Pregnant or lactating woman
- •People medically prescribed medications within the last month that would affect the immune and/or the inflammatory response excluding topical steroid use.
- •Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
- •Participants with cognitive damage
- •Participants with seasonal allergic rhinitis
- •Regular use of antihistamines
- •Individuals deemed unsuitable for participation by the Principal Investigator (PI) of this study.
研究组 & 干预措施
LC-Plasma
Experimental
1 tablet containing 50mg LC-Plasma is taken daily for 24 weeks.
干预措施: LC-Plasma (Dietary Supplement)
Placebo
Placebo Comparator
1 tablet containing 50mg microcrystalline cellulose is taken daily for 24 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Cumulative incidence number of URTIs
时间窗: Day 1 to 24 weeks
Cumulative incidence number of Upper Respiratory Tract Infections (URTIs)
次要结局
- Cumulative number of infected participants(Day 1 to week 24)
- Cumulative number of days that participant recorded symptom positive to WURSS-24 system(Day 1 to week 24)
- Cumulative scores of each parameter in WURSS-24 scoring system, as well as the total sum of all parameters for each participant.(Day 1 to week 24)
- Length of URTI symptomatic days per one URTI episode.(Day 1 to week 24)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)EmphysemaNCT01334307Boston Scientific Corporation47
已完成
1 期
Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse RateHypertensionNCT01591967Spinal Missions, Inc., LLC290
已完成
不适用
A Trial on the Effects of Bronchoscopic Lung Volume Reduction in Severe Emphysema.EmphysemaNCT03474471University Medical Center Groningen96
已完成
3 期
Inhaled Nitrous Oxide for Pain Relief During Eye Exam in the Pre-term InfantRetinopathy of PrematurityNCT00623220Nabeel Ali40
终止
2 期
Acute Effects of Inhaled Treprostinil in Fontan PatientsCongenital Heart DiseaseNCT02769624Children's Hospital Medical Center, Cincinnati15