NCT01044030已完成3 期
Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 2
- 主要终点
- Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media
研究概览
简要总结
The primary objective of the proposed study is to determine the effectiveness and safety of orally administered viscous-adherent xylitol syrup given in a dose of five grams three times daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear infection) in children with a history of recurrent acute otitis media.
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
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Six months to five years of age
- •General good health
- •History of at least three episodes of AOM in previous 12 months, at least one of which occurred within the previous six months
- •English or Spanish speaking
排除标准
- •History of tympanostomy tubes
- •Intestinal malabsorption or chronic diarrhea
- •Diabetes mellitus
- •Any inborn error of metabolism
- •Parent/guardian unreachable by telephone
- •Known allergy to any of the study solution components (xylitol, sorbitol, sodium carboxymethylcellulose, potato starch, glycerin, potassium sorbate, natural berry flavoring).
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Xylitol syrup
Experimental
干预措施: Xylitol syrup (Drug)
结局指标
主要结局
Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media
时间窗: 12 weeks
Proportion of subjects who remained free of acute otitis media throughout the study period
次要结局
- Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media(12 weeks)
- Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae(12 weeks)
- Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo.(12 weeks)
研究者
Louis Vernacchio
Principal Investigator
Boston Children's Hospital
研究点 (2)
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