5HTP 调节儿童哮喘
The purpose of this study is to learn more about if taking a supplement called 5-hydroxytryptophan (5HTP) can improve breathing and anxiety symptoms related to asthma. To help learn more subjects will either be assigned to a group that is taking the supplement (5HTP) or a group that is taking a placebo. This will be decided randomly. Later in the study subjects will crossover to the other group.There are 5 study visits over the course of about 12 weeks.
研究概览
详细说明
The objective of this study is to test the hypothesis that over-the-counter amino acid supplement 5HTP (isolated from the plant Griffonia Simplifolia) reduces human allergic lung responses and consequently improves lung function. The primary outcome is the change in FEV1. We anticipate the 5HTP at the proposed doses will improve lung function as in preclinical studies that used clinically relevant 5HTP. Secondary outcomes will be blood eosinophil counts and reduced symptoms for anxiety/depression, as seen in changes in the anxiety-depression scores from questionnaires (CES-DC & SCARED). The results from these studies have the transformative potential to influence approaches to improve lung function and asthma-associated anxiety/depression.
- Aim 1: Test that 5HTP improves lung function in children with allergic asthma
- Aim 2: Test that 5HTP reduces eosinophil numbers in the blood and nasal fluid of patients with asthma from Aim 1
- Aim 3: Test that 5HTP decreases lung inflammation, increases cortisol and prolactin without altering systemic plasma concentrations of 5HTP, serotonin, 5-hydroxyindoleacetic acid (5-HIAA), and dopamine
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Kirsten Kloepfer, MD
- 电话号码：(317) 278-7860
- 邮箱：kloepfer@iu.edu
研究联系人备份
- 姓名：Lisa Bendy, MBA
- 电话号码：(317) 278-7218
- 邮箱：lbendy@iu.edu
学习地点
-
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Indiana
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Indianapolis、Indiana、美国、46202
- 招聘中
- Indiana University
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接触：
- Lisa Bendy, MBA
- 电话号码：317-278-7152
- 邮箱：lbendy@iu.edu
-
接触：
- Lisa Bendy, MBA
- 电话号码：3172787152
- 邮箱：lbendy@iu.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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Age 8-18 Years of Age
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Mild to Moderate Asthma based on ATS guidelines
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Positive Allergy Test (positive skin or serum IgE)
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Weight ≥ 70 lbs (32 kg)
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CES-DC cut-off ≥ 15 (total score range is 0 to 60) or SCARED cut-off
- 25 (total score range is 0 to 142)
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Ability to comply with study visits and study procedures
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Informed Consent by participant and if applicable the parent or legal guardian
Exclusion Criteria:
- Currently taking a SSRI
- Taking a leukotriene inhibitor (montelukast, Zileuton)
- Severe Asthma Based on ATS Guidelines
- Taking a biologic medication (omalizumab, mepolizumab, benralizumab, dupilumab)
- Medical History of Adverse Reaction to 5HTP
- Physical findings that would compromise the safety of the study or the quality of the study data
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：5-hydroxytryptophan
Dosage of 5-hydroxytryptophan will be determined by weight: If subject weighs less than 100lbs: 50mg twice a day If subject weights more than 100lbs: 100mg twice a day |
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
其他名称：
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安慰剂比较：Placebo
Dosage of placebo will be determined by weight: If subject weighs less than 100lbs: 50mg twice a day If subject weights more than 100lbs: 100mg twice a day |
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1)
大体时间：77 days
|
Pulmonary function testing will be performed at Baseline, Day 28, and Day 49, and Day 77 |
77 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood will be obtained to assess Eosinophil Count
大体时间：77 days
|
Will be performed at Baseline, Day 28, and Day 49, and Day 77 |
77 days
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Questionnaires will be utilized to look for a decrease in symptoms for Anxiety/Depression Reduced Symptoms for Anxiety/Depression
大体时间：77 days
|
Changes in Anxiety/Depression will be determined via questionnaire that will be administered at Baseline, Day 28, and Day 49, and Day 77 . Will use the Center for Epidemiological Studies Depression Scale for Children (CES-DC) to measure depression and Screen for Child Anxiety Related Disorders (SCARED) |
77 days
|
合作者和调查者
调查人员
- 首席研究员：Kirsten Kloepfer, MD、Indiana University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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