5HTP Regulation Of Asthma In Children
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8-18 Years of Age
- •Mild to Moderate Asthma based on ATS guidelines
- •Positive Allergy Test (positive skin or serum IgE)
- •Weight ≥ 70 lbs (32 kg)
- •CES-DC cut-off ≥ 15 (total score range is 0 to 60) or SCARED cut-off
- •25 (total score range is 0 to 142)
- •Ability to comply with study visits and study procedures
- •Informed Consent by participant and if applicable the parent or legal guardian
排除标准
- •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
研究组 & 干预措施
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
干预措施: Placebo (Drug)
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
干预措施: 5-Hydroxytryptophan (Drug)
结局指标
主要结局
Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1)
时间窗: 77 days
Pulmonary function testing will be performed at Baseline, Day 28, and Day 49, and Day 77
次要结局
- Blood will be obtained to assess Eosinophil Count(77 days)
- Questionnaires will be utilized to look for a decrease in symptoms for Anxiety/Depression Reduced Symptoms for Anxiety/Depression(77 days)
研究者
Kirsten Kloepfer
Assistant Professor of Pediatrics; Division of Pulmonary, Allergy and Sleep Medicine; Riley Hospital for Children at Indiana University Health
Indiana University