A Food Additive Removal Diet for Pediatric Eosinophilic Esophagitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Eosinophils Per High Power Field (eos/hpf)
研究概览
简要总结
Prospective, pragmatic standard of care clinical trial comparing dietary therapies of standard dairy elimination diet alone (DED) to dairy elimination plus food additive elimination (FREE)
详细描述
Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder of the esophagus. Primary symptoms manifest while eating and include dysphagia, chest pain, and food impaction. EoE was first described in the 1990s, but is increasingly recognized worldwide. It affects both adults and children.
Given that EoE is thought to be an allergen driven disease, elimination diets are considered logical and safe first-line treatment options. Elimination diets focus on the removal of the food groups most likely to evoke the inflammatory response (e.g. dairy, wheat, soy, egg, etc.). This is the first study to examine the effects of an additive free diet on eosinophilic esophagitis.
Primary Objective: To compare histologic outcomes (eosinophils per high power field: eos/hpf) of DED and FREE in children with eosinophilic esophagitis.
Secondary Objective: To compare endoscopic outcomes (Eosinophilic Esophagitis Endoscopic Reference scores: EREFs) of DED and FREE in children with eosinophilic esophagitis
Tertiary Objectives: To compare symptomatic (Pediatric Eosinophilic Esophagitis Symptom Severity Module v2.0: PEESS) and quality of life (Peds-QL EoE Module 1) outcomes of DED and FREE in children with eosinophilic esophagitis
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
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An Institutional Review Board (IRB) approved written Parental Permission form is signed and dated by the parent or legal representative/caregiver.
- •If applicable, an Institutional Review Board (IRB) approved written Assent form is signed and dated by the participant.
- •The participant/parent(s) or legal representative(s)/caregiver(s) are considered reliable and capable of adhering to the protocol call schedule and dietary requirements.
- •The participant is >2 years to <18 years of age.
- •The participant has isolated esophageal eosinophilia (>15 eos/hpf).
- •The family has access to the internet to complete weekly surveys and to a telephone to complete weekly follow up calls.
- •The biopsy used to diagnose eosinophilic esophagitis was taken no more than 12 weeks prior to the date of enrollment.
排除标准
- •The participant has peripheral eosinophilia > 1,500 µL
- •The participant has concomitant GI inflammatory conditions (e.g. celiac disease, inflammatory bowel disease).
- •The participant has a history of upper GI tract surgery (e.g. fundoplication)
- •Acid reflux by pH probe is suggested (*A pH probe is not required, but may be done as standard of care)
- •The participant has severe developmental delay that, in the opinion of the investigator, could jeopardize the participant's ability to participate in the study.
- •The participant has taken prednisone in the last 12 weeks, or has taken fluticasone or budesonide in the last 8 weeks.
- •The participant has other significant medical conditions that, in the opinion of the provider, would impact the participant's ability to participate in the study.
- •The participant has a psychiatric condition that, in the opinion of the investigator, could jeopardize the participant's ability to participate in the study.
- •The participant does not speak or read English fluently.
- •The participant is currently taking a PPI (If discontinued, no washout required.)
- •The participant is currently on or previously failed a dairy free diet for EoE.
研究组 & 干预措施
DED
Diet eliminating dairy
干预措施: DED (Other)
FREE
Diet eliminating dairy and food additives
干预措施: FREE (Other)
结局指标
主要结局
Eosinophils Per High Power Field (eos/hpf)
时间窗: 12 weeks
Histologic change differences of maximum eosinophils per high power field
次要结局
- Eosinophilic Esophagitis Endoscopic Reference Score (EREFS)(12 weeks)
研究者
Edward Mougey
Research Scientist
Nemours Children's Clinic