Immunomodulatory Effect of Pleuran (β-glucan From Pleurotus Ostreatus) in Children With Recurrent Respiratory Tract Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 3
- 主要终点
- change in the number of RTIs episodes (total number)
研究概览
简要总结
International, multicentre, prospective, randomized, double-blind, placebo-controlled study with a food supplement Imunoglukan P4H® chewable tablets to evaluate preventive effect on reduction of respiratory tract infections (RTIs) in children with a history of recurrent respiratory tract infections (RRTIs) in the previous infectious season prior enrolment.
Participants or their guardians will record the incidence and duration of RTIs in the Patient diary for 3 months.
详细描述
Study population:
Children aged 3-18 years with a history of RRTIs:
- Age 3 to 5 years (< 6 years): 6 or more upper or lower respiratory tract infections from October 2022 until the end of March 2023
- Age 6 to 18 years (≥ 6 years): 3 or more upper or lower respiratory tract infections from October 2022 until the end of March 2023
Study design:
International (Slovak republic, Czech republic, Serbia), multicentre (36), prospective, randomized, double-blind, placebo-controlled 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, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •age 3-18 years
- •history of recurrent respiratory infections:
- •Age 3 to 5 years (< 6 years): 6 or more upper or lower respiratory tract infections from October 2022 until the end of March 2023
- •Ages 6 to 18 years (≥ 6 years): more than 3 upper or lower respiratory tract infections from October 2022 until the end of March 2023
排除标准
- •refused informed consent
- •bronchopulmonary dysplasia
- •primary immunodeficiency
- •cystic fibrosis
- •chronic diarrhoea
- •chronic diseases of the lungs, kidneys and liver
- •malformations of the cardiovascular system
- •oncological disease
- •malnutrition
- •intolerance to any of the ingredients in the study product
- •taking preventive immunomodulatory therapy (beta-glucans, bacterial lysates, isoprinosine) less than 14 days prior enrolling the patient into the study
研究组 & 干预措施
Active group
Dietary supplement Imunoglukan P4H® chewable tablets (tablet containing IMG® 50 mg + Zinc 5 mg + Vitamin D 10 μg in 1 tablet)
Dosage:
up to 25 kg 1 tablet once daily for 3 months over 25 kg 2 tablets once daily for 3 months
干预措施: Imunoglukan P4H® chewable tablets (Dietary Supplement)
Placebo group
Active Placebo Comparator (tablet containing 5 mg zinc + 10 μg vitamin D3)
Dosage:
up to 25 kg 1 tablet once daily for 3 months over 25 kg 2 tablets once daily for 3 months
干预措施: Placebo chewable tablets (Dietary Supplement)
结局指标
主要结局
change in the number of RTIs episodes (total number)
时间窗: change in the number of RTIs episodes (total number) during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
number of episodes of respiratory infections will be compared between the two study goups
次要结局
- change in the number of episodes of RTI subtypes(change in the number of RTIs episodes (subtypes) during 3 month supplementation (from enrollment to the end of the treatment at 3 months))
- change in the duration of RTI episodes (total duration, RTI subtypes)(change in the duration of RTIs episodes (total duration, subtypes) during 3 month supplementation (from enrollment to the end of the treatment at 3 months))
- change in the number of antibiotic therapy courses(change in the number of antibiotic (ATB) therapy courses during 3 month supplementation (from enrollment to the end of the treatment at 3 months))
- change of the number of missed days at school/nursery due to RTI(change of the number of missed days at school/nursery due to RTI during 3 month supplementation (from enrollment to the end of the treatment at 3 months))
- change of the number of missed working days due to RTIs(change of the number of missed working days due to RTIs during 3 month supplementation (from enrollment to the end of the treatment at 3 months))
- changeof the number of emergency department visits due to RTI(changeof the number of emergency department visits due to RTI during 3 month supplementation (from enrollment to the end of the treatment at 3 months))
- change of the number of physician visits due to RTI(change of the number of physician visits due to RTI during 3 month supplementation (from enrollment to the end of the treatment at 3 months))
- tolerability and safety(during 3 month supplementation (from enrollment to the end of the treatment at 3 months))