NCT02453126招募中不适用
Fibrostenotic Eosinophilic Esophagitis: Endoscopic, Histologic and Molecular Characterization and Evaluation of Clinical Assessment Tools
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Stricture, as measured by endoscopic assessment
研究概览
简要总结
This protocol addresses a central hypothesis that fibrostenotic Eosinophilic Esophagitis (EoE) is characterized by abnormal esophageal structure and compliance compared to non fibrostenotic EoE and that distinctive cellular and molecular profiles predict the fibrostenotic phenotype. This study aims to define and assess the changes that occur in the structure and dynamics of the esophageal wall in pediatric Eosinophilic Esophagitis along with characterizing the histologic and molecular patterns in fibrostenotic EoE.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo a clinical upper endoscopy with biopsy
排除标准
- •Known connective tissue disorder
- •Increased risk of bleeding
- •Inflammatory bowel disease, celiac disease, eosinophilic gastroenteritis, or any autoimmune disease
- •Other esophageal disease including known achalasia; history of caustic ingestion, esophageal surgery esophageal stricture for other known reason or other esophageal injury.
- •Use of oral or intravenous steroids in the preceding 60 days. (Swallowed topical fluticasone, budesonide, etc not included as exclusion criteria.)
结局指标
主要结局
Stricture, as measured by endoscopic assessment
时间窗: Day 1
次要结局
- Decreased esophageal distensibility, as determined by EndoFlip(Day 1)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Allergy Immunotherapy in the Management of Eosinophilic EsophagitisEosinophilic EsophagitisNCT01685034United States Naval Medical Center, San Diego
已完成
1 期
Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic EsophagitisEosinophilic EsophagitisNCT01386112Forest Laboratories24
已完成
2 期
Off Label Use of Infliximab in Adult Patients With Severe Eosinophilic EsophagitisEsophagitisNCT00523354Swiss EE Study Group
已完成
2 期
A Pilot Study of the Treatment of Eosinophilic Esophagitis With OmalizumabEsophagitisNCT00123630University of Utah30
招募中
不适用
EDN and Eosinophilic EsophagitisEosinophilic EsophagitisNCT06387030Assistance Publique - Hôpitaux de Paris60