A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear
研究概览
简要总结
This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole) will increase the rate of resolution of chronic middle ear fluid in children.
详细描述
This study is being done to see if reflux of stomach fluid might be a cause of fluid in the ears. Earlier studies have found pepsin or pepsinogen, a component of stomach fluid, in the middle ear fluid of many children with chronic middle ear fluid. Anti-reflux medicines called proton pump inhibitors (PPI) reduce the acidity of the contents of the stomach and the activity of pepsin or pepsinogen. We are studying the effectiveness of a PPI called lansoprazole (Prevacid™) in reducing fluid in the ears. If lansoprazole is able to reduce the fluid in the middle ear, this tells us that the reflux of gastric acid into the esophagus and into the ear canal may be causing middle ear fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of chronic otitis media with effusion meeting clinical indications for tympanostomy tubes placement, defined as the presence of middle ear fluid on physical exam for at least 3 months, in at least one ear.
排除标准
- •Past medical history or concurrent conditions known to increase the incidence of either recurrent otitis media or otitis media with effusion or gastroesophageal reflux disease, including cleft palate, neurological delay, cerebral palsy, Down syndrome, velocardiofacial syndrome, and primary ciliary dyskinesia.
- •Children with structural abnormalities of the tympanic membranes, such as cholesteatoma, deep retraction pockets, and atelectasis of the tympanic membrane. These abnormalities would require placement of tympanostomy tubes in standard clinical practice.
- •Children weighing less than 10 kilograms, due to the lower weight limit for standard Prevacid™ dosing
研究组 & 干预措施
Lansoprazole (Prevacid)
Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
干预措施: lansoprazole (Drug)
Placebo
Placebo SoluTab once daily for 2 months
干预措施: placebo (Drug)
结局指标
主要结局
Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear
时间窗: 2 months
Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar
时间窗: 2 months
次要结局
- Acoustic Reflectometry: Level of Risk as Defined by Manufacturer(2 months)
- Number of Participants With Normal Type A Tympanometry(2 months)
- Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire(2 months)
研究者
Judith Lieu
Assistant Professor
Washington University School of Medicine