5HTP Regulation Of Asthma In Children

• Status: Unknown status
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Treatments: 5-Hydroxytryptophan

Criteria

Inclusion Criteria:

• Age 8-17 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

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