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5HTP Regulation Of Asthma In Children

RecruitingPhase 2

Sponsor: Indiana University

Conditions: Mild or Moderate Asthma With Allergic Sensitization

Interventions: 5-Hydroxytryptophan, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 8 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Indianapolis, Indiana, United States