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Recruiting
NCT04160910
5HTP Regulation Of Asthma In Children
Conditions: Mild or Moderate Asthma With Allergic Sensitization
Sex: All
Ages: 8 Years – 18 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 20
Sponsor: Indiana University
Location: Indiana University Indianapolis Indiana
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 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
Source: ClinicalTrials.gov (NCT04160910). StuddyBuddy aggregates publicly available trial information.