NCT05577065已完成不适用
A Randomised, Double-blinded, Placebo-controlled, Parallel Study, to Assess the Effect of a Probiotic on the Incidence, Duration and Severity of Upper Respiratory Tract Infections in Healthy Children
The Archer-Daniels-Midland Company2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI)
研究概览
简要总结
This study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children.
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
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a parent/guardian able to give written informed consent.
- •If ≥7 years, be able to give written informed assent.
- •Healthy children aged 2 - 8 years old.
- •In general good health, as determined by the investigator.
- •Attending a registered childcare provider or school.
- •Willing to consume the study product daily for the duration of the study.
排除标准
- •Has URTI symptoms at the time of randomisation.
- •Are <2 or ≥9 years old.
- •Diagnosed with concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma - generally only formally diagnosed after child is 6 years), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis or congenital cardiac defects.
- •Has a family household member that smokes cigarettes in the home.
- •Has taken antibiotics within the previous 2 weeks prior to randomisation.
- •Has taken probiotic supplements within the previous 2 weeks prior to randomisation
- •Daily intake of immune stimulating products, including but not limited to echinacea, vitamin C and zinc in the 2 weeks before randomisation (multivitamins allowed).
- •Has any significant health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.
- •Taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
- •Has an active gastrointestinal disorder or previous gastrointestinal surgery (appendicectomy allowed).
- •Has a gastrointestinal or chronic infective disease (i.e., coeliac disease, diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.), or with a history of such diseases.
- •Planned extensive travel (for >1 month) during the study duration.
- •Parent/guardian who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- •Participants may not be receiving treatment involving experimental drugs. If the Participant has been in a recent experimental trial/study, these must have been completed not less than 60 days prior to this study.
- •Any Participant who is the child of an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
结局指标
主要结局
Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI)
时间窗: Entire follow up period (total of 180 days)
Presence of an URTI defined by a score of \>2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline
次要结局
- Effect of 26 week consumption of probiotic on Salivary Immunoglobulin A levels (IgA) (mg/dL)(Day 0, Day 180)
- Effect of 26 week consumption of probiotic on the incidence of gastrointestinal infections(Day 0, Day 90, Day 180)
- Effect of 26 week consumption of probiotic on the average duration of URTIs reported by participants(Day 0, Day 90, Day 180)
- Effect of 26 week consumption of probiotic on the total number of reported missed days of school/childcare due to illness(Day 0, Day 90, Day 180)
- Effect of 26 week consumption of probiotic on the reported incidence of antibiotic use(Day 0, Day 90, Day 180)
- Effect of 26 week consumption of probiotic on the number of children reporting at least one URTI(Day 0, Day 90, Day 180)
- Effect of 26 week consumption of probiotic on the severity of URTI-related symptoms reported by participants(Day 0, Day 90, Day 180)
研究者
研究点 (2)
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