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5HTP Regulation Of Asthma In Children

RECRUITINGPhase 2Sponsored by Indiana University
Actively Recruiting
PhasePhase 2
SponsorIndiana University
Started2021-02-11
Est. completion2026-06-30
Eligibility
Age8 Years – 18 Years
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 8 Years – 18 YearsHealthy volunteers accepted
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

Conditions3

AsthmaCancerMild or Moderate Asthma With Allergic Sensitization

Locations1 site

Indiana University
Indianapolis, Indiana, 46202
Patrick T Campbell, BS317-278-7117ptc@iu.edu

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