ACTRN12619000141145尚未招募3 期
Two food group elimination diet versus swallowed fluticasone for the management of adult eosinophilic esophagitis, a single- centred randomised prospective study
Department of Gastroenterology and Hepatology, Royal Brisbane and Women's Hospital0 个研究点目标入组 194 人开始时间: 2019年1月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 194
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Adults over the age of 18 with a diagnosis of eosinophilic esophagitis defined by consensus guidelines (symptoms of oesophageal dysfunction + more than or equal to 15 eosinophils / high powered field on oesophageal biopsies despite 8 weeks of treatment with PPIs to exclude PPI responsive eosinophilia) who were naïve for topical steroid or dietary therapy.
排除标准
- •Patients with potential cause for eosinophilia different from eosinophilic esophagitis (e.g. achalasia, caustic or radiation esophagitis, parasites, Inflammatory Bowel Disease, neoplasms and drugs)
- •patients with food associated anaphylaxis to milk and wheat
- •patients with severe fibro-stricturing eosinophilic esophagitis
- •patients in whom esophageal biopsies would be contraindicated (presence of varices or anti coagulation / anti platelets at high risk of thrombotic/ cardio vascular event if withheld)
- •Patients who are on oral or inhaled steroids for other indication will be excluded from this study.
- •Patients who lack capacity to provide written consent.
研究者
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