Status:
RECRUITING
5HTP Regulation Of Asthma In Children
Lead Sponsor:
Indiana University
Conditions:
Mild or Moderate Asthma With Allergic Sensitization
Eligibility:
All Genders
8-18 years
Phase:
PHASE2
Brief 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...
Detailed Description
The objective of this study is to test the hypothesis that over-the-counter amino acid supplement 5HTP (isolated from the plant Griffonia Simplifolia) reduces human allergic lung responses and consequ...
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
Key Trial Info
Start Date :
February 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04160910
Start Date
February 11 2021
End Date
June 30 2026
Last Update
March 2 2026
Active Locations (1)
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1
Indiana University
Indianapolis, Indiana, United States, 46202