NCT07787130尚未招募不适用
The Effect of Immune X on the Incidence of the Common Cold in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Participants With at Least One Clinically Confirmed Cold Event
研究概览
简要总结
The goal of this clinical trial is to learn if Immune X can help prevent common cold events in healthy adults who have a history of upper respiratory tract infections. The main questions it aims to answer are:
- Does Immune X reduce the proportion of participants who experience at least one clinically confirmed common cold event during the study period?
- Does Immune X affect the number, duration, and severity of common cold events?
Researchers will compare Immune X to a placebo (a look-alike capsule containing inactive ingredients) to see if Immune X helps prevent common cold events.
Participants will:
- Take Immune X or placebo daily for 16 weeks during the winter season.
- Attend study visits at the beginning and end of the study and complete questionnaires and symptom assessments throughout the study.
- Record cold symptoms, medications, and other study information using a smartphone application.
- Provide blood and stool samples during the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 to 65 years.
- •History of at least two upper respiratory tract infections during the previous winter season.
- •Body mass index between 18 and 30 kg/m².
- •Generally healthy, as determined by the investigator.
- •Women of childbearing potential must have a negative pregnancy test and agree to use an effective method of contraception during the study.
- •Covered by French health insurance.
- •Able and willing to provide written informed consent.
排除标准
- •Current or recent upper respiratory tract infection or COVID-19 infection within 2 weeks before enrollment.
- •Acute gastrointestinal infection, including gastroenteritis, within 2 weeks before enrollment.
- •Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before enrollment.
- •Use of systemic antibiotics within 3 months before enrollment.
- •Receipt of any vaccination within 6 weeks before enrollment.
- •Surgery requiring general anesthesia within 1 month before enrollment.
- •History of chronic respiratory disease, including asthma or chronic obstructive pulmonary disease.
- •Food allergy or chronic/recurrent allergic upper airway conditions requiring regular medical treatment, including moderate to severe allergic rhinitis, hay fever, or chronic rhinosinusitis.
- •Acute lower respiratory tract infection within 6 months before enrollment or ongoing long COVID.
- •Immunodeficiency (including HIV infection) or autoimmune disease, except stable hypothyroidism.
- •Severe or uncontrolled chronic disease, including cancer, significant liver, pancreatic, biliary, or renal disease, inflammatory bowel disease, or cardiovascular disease requiring intensive medical management.
- •Untreated or inadequately controlled diabetes.
- •History or current diagnosis of periodontitis.
- •Current chemotherapy, immunosuppressive therapy, or chronic treatment with corticosteroids or opioids.
- •Specific diets or major dietary changes within 3 months before enrollment, including high-protein, vegan, low-calorie, or low-FODMAP diets, or participation in a weight-loss program.
- •Current use of dietary supplements that may affect immune or gut microbiota parameters, or discontinuation of such supplements less than 6 weeks before enrollment.
- •Current smoking or e-cigarette use, or smoking cessation within 6 months before enrollment.
- •Current drug or alcohol abuse, or a history of abuse within the previous 12 months.
- •Regular consumption of more than 2 alcoholic drinks per day and unwillingness to maintain stable drinking habits during the study.
- •Unwillingness to refrain from using over-the-counter cold remedies, nasal washes or sprays, antihistamines, corticosteroids, or NSAIDs during the study.
- •More than 8 hours per week of vigorous physical activity or planned major changes in physical activity during the study.
- •Any condition or circumstance that, in the investigator's judgment, may place the participant at unacceptable risk or interfere with study participation or interpretation of study results.
- •Current participation in another clinical trial or being in an exclusion period from a previous clinical trial.
- •Pregnant or breastfeeding.
- •Persons deprived of liberty, under legal protection, or unable to provide informed consent.
- •Individuals who have reached the regulatory compensation limit for participation in clinical research.
结局指标
主要结局
Participants With at Least One Clinically Confirmed Cold Event
时间窗: Week 2 to Week 16
Proportion of participants with at least one clinically confirmed cold event.
次要结局
- Use of Rescue Medication During Cold Events(Week 2 to Week 16)
- Number of Clinically Confirmed Cold Events(Week 2 to Week 16)
- Duration of Clinically Confirmed Cold Events(Week 2 to Week 16)
- Upper Respiratory Symptoms of Clinically Confirmed Cold Events(Week 2 to Week 16)
- Cold Symptoms of Clinically Confirmed Cold Events(Week 2 to Week 16)
- Illness-Specific Quality of Life During Cold Events(Week 2 to Week 16)
- Time to First Clinically Confirmed Cold Event(Week 2 to Week 16)
- Fatigue(Baseline, Weeks 4, 8, 12, and 16)
- Number of Cold Events (Clinically Confirmed and Unconfirmed)(Week 2 to Week 16)
- Adverse Events(Baseline through Week 16)
研究者
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