Comparison of Esophageal Clearance Times of Oral Budesonide Preparations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Esophageal Mucosal Contact Time
研究概览
简要总结
The purpose of this study is to determine if a xanthan gum or honey based budesonide slurry exhibit comparable mucosal contact time to a budesonide/sucralose slurry in healthy adult subjects.
详细描述
This study will be a blinded randomized cross over trial study, comparing one of two alternative slurries (xanthan gum or honey) against the current standard sucralose slurry in each subject and determining esophageal clearance for each.
A total of 24, up to 30 healthy adult subjects will be enrolled and randomized to their treatment group by sequentially numbered, opaque, sealed envelopes (SNOSE) prepared by an uninvolved third party. These envelopes will be labeled numerically "Subject 1" through "Subject 24", and will randomly contain which treatment will be administered, and in what order. If additional subjects are recruited, 6 additional SNOSE will be prepared in a similar manner. There will be 4 types envelopes prepared- Sucralose-Xanthan Gum, Xanthan Gum-sucralose, Sucralose-Honey and Honey-Sucralose. One of these regimens will be randomly inserted into an opaque envelope as described previously and sealed. The envelope will be given to the subject after enrollment and consent, and will be opened by the nuclear medicine pharmacist to determine the assigned preparation that will be compounded and administered. Subjects will be randomized in a 1:1:1:1 ratio using a computer program based on random number generation.
The sucralose slurry will consist of 10 grams of sucralose mixed with 4ml of 0.5mg/2ml nebulized budesonide solution (for a total budesonide dose of 1mg) and 1mCi (1ml) of Tc99 sulfur colloid for a total volume of approximately 10ml.
The honey slurry will consist of 5ml of honey mixed with 4ml of 0.5mg/2ml nebulized budesonide solution (for a total budesonide dose of 1mg) and 1mCi (1ml) of Tc99 sulfur colloid for a total volume of approximately 10ml.
The xanthan gum slurry will consist of 50mg xanthan gum powder mixed with 4ml of a 0.5mg/2ml nebulized budesonide solution (for a total budesonide dose of 1mg), along with a flavoring packet of cold pressed crystallized orange flavor and 1mCi (1ml) of Tc99 sulfur colloid and 5ml of distilled water for a total volume of approximately 10ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DEERS eligible
- •Older than 18 y/o, without diagnosis of Eosinophilic Esophagitis or other esophageal disease
排除标准
- •History of EoE, esophageal surgery or known achalasia/stricture or previously diagnosed GERD or GER that requires more frequent than once a week treatment.
- •Peripheral eosinophil count above 0.5 X10^3 / mcL.
- •Pregnancy or breastfeeding
- •Previous adverse reaction to budesonide, honey, or oranges.
结局指标
主要结局
Esophageal Mucosal Contact Time
时间窗: 1 hour
Comparison of esophageal contact time of sucralose slurry vs either honey slurry or xanthan gum based slurry. 1 hour will elapse between ingestions.
次要结局
- Taste preference(1 minute after slurry is ingested)