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临床试验/NCT03354221
NCT03354221撤回不适用

A Pilot Study Assessing the Efficacy of Short Duration Six Food Elimination Diet in Eosinophilic Esophagitis (EoE)

Mayo Clinic2 个研究点 分布在 1 个国家开始时间: 2017年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Mayo Clinic
试验地点
2
主要终点
Cytosponge pathology: number of Eosinophils directing dietary therapy

研究概览

简要总结

This research is being done to see if the investigators can use the cytosponge or esophacap (depending on availability) to determine if shorter duration SFED (two weeks versus six weeks) would have equal results.

详细描述

Dietary therapy has been shown to be successful in the treatment of adult and pediatric patients with eosinophilic esophagitis (EoE). Dietary studies were initially reported in children, but the results appear to be similar in adult patients. Elemental diets are successful in 70-95% of patients but are poorly tolerated.

The six food elimination diet (SFED) involves the elimination of the six most common food allergens (i.e. milk, wheat, soy, eggs, nuts, and fish) for six weeks and has become the mainstay of dietary therapy in EoE. A six week SFED has demonstrated excellent efficacy and durability in both pediatric and adult EoE. However, compliance with the SFED for a total of six weeks can be challenging for patients.

Previous studies have found the esophageal sponge to be an accurate technique of accessing esophageal eosinophilia in EoE . The sponge is swallowed as a 12 mm capsule on a string. The capsule rapidly dissolves upon entering the stomach and the sponge then expands and can be pulled out the mouth five minutes after ingestion. In previous studies, the procedure was very well tolerated and all patients preferred the sponge to endoscopy. Therefore the sponge is a well tolerated, inexpensive, very low risk procedure that would be an ideal option to replace EGD esophageal sampling in the evaluation of dietary treatment of EoE.

Although initially described as a six week trial, it is possible that a shorter duration food elimination diet of 2 or 4 weeks would have equal efficacy. This would have important implications for patients as it would make the diet more tolerable.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Cytosponge pathology: number of Eosinophils directing dietary therapy

时间窗: 2 years

Patients will swallow the cytosponge at 2 weeks, 4 weeks and 6 weeks into the initial period of the 6 food elimination diet. Eosinophils \<15 phf will be considered histologic remission to dietary therapy. This response will be compared to the 6 week visit sponge eosinophilic histology.

次要结局

  • Eosinophilic Esophgitis Activity Index Pro (EEsAI Pro)(2 years)
  • The tolerability of esophageal sponge compared to upper endoscopy with biopsy.(6 weeks)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karthik Ravi, M.D.

Principal Investigator

Mayo Clinic

研究点 (2)

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