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RECRUITINGPhase 2INTERVENTIONAL

5HTP Regulation Of Asthma In Children

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - willing to sign a consent form by participant and if applicable the parent or legal guardian Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 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

Treatments Being Tested

DRUG

5-Hydroxytryptophan

Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study

DRUG

Placebo

Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study

Locations (1)

Indiana University
Indianapolis, Indiana, United States