Pilot Interventional Study of an EoE-Causal Food Identification Blood Test
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Esophageal eosinophilia (number of eosinophils in the esophagus)
研究概览
简要总结
The objective of this study is to determine the performance characteristics of a series of novel, non-invasive allergen-activated T cell assays designed to identify Eosinophilic esophagitis (EoE) causal foods, when used in conjunction with standard-of-care (SOC) practices.
The question it aims to answer is:
Will assay results accurately predict EoE food allergies in concordance with SOC endoscopies after diet changes?
详细描述
This proof-of-concept, interventional prospective cohort study will enroll subjects with Eosinophilic esophagitis (EoE) who have not yet identified causal foods. Subject blood will be drawn and food-activated T cell responses will be assayed. Subjects will be advised to remove foods based on standard-of-care practices and/or the outcome of their T cell assays ("personalized elimination diet"). Symptoms will be measured by the Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS) Child and Parent Surveys and standard of care (SOC) endoscopy with esophageal biopsy, respectively. Response to research assay-directed diet changes will provide information about the assay's clinical value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Eosinophilic esophagitis (EoE) based on positive esophageal biopsy (>15 eosinophils/high power field) within three months of enrollment.
- •AND Intention to undergo dietary intervention for treatment of their EoE. AND Unknown contribution of one or more of milk, soy, egg, and wheat to their EoE disease state.
- •AND Willingness to adopt an elimination diet based in part on the results of the experimental testing.
排除标准
- •Proton pump inhibitor (PPI)-responsive EoE: Resolution or response of EoE to high-dose PPI (2 mg/kg) alone, at the PI's discretion.
- •OR Presence of other inflammatory or infectious gastrointestinal pathology (e.g. eosinophilic gastrointestinal diseases, irritable bowel disease, Infectious Colitis, etc.), at the discretion of the Principal Investigator (PI).
- •OR Prior medical or surgical history that precludes safely performing an upper endoscopy with biopsy or restriction of diet.
- •OR Current immunomodulatory therapy >4 weeks (swallowed or systemic steroids, biologic therapy, chemotherapy. etc.) that may interfere with the blood test or biopsy results, at the PI's discretion.
- •OR Inability to read or understand English.
研究组 & 干预措施
EoE unknown
Patients with Eosinophilic esophagitis who have not yet identified their disease causal foods and are interested in an elimination diet approach to disease management
干预措施: Assay directed diet change (Diagnostic Test)
结局指标
主要结局
Esophageal eosinophilia (number of eosinophils in the esophagus)
时间窗: At least 4 weeks after implementation of diet changes
Eosinophils per high power field on follow up esophageal biopsy
次要结局
- Pediatric Eosinophilic Esophagitis Symptom Score (total score based on pediatric symptom score)(At least 4 weeks after implementation of diet changes)