Actively Recruiting
5HTP Regulation Of Asthma In Children
Led by Indiana University · Updated on 2026-03-02
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the supplement 5-hydroxytryptophan (5HTP) can improve breathing and reduce anxiety symptoms in children with mild to moderate allergic asthma. This phase 2 study aims to test if 5HTP reduces allergic lung responses, improves lung function measured by Forced Expiratory Volume at one second (FEV1), lowers blood eosinophil counts, and decreases anxiety and depression symptoms. The study is sponsored by Indiana University. Participants will receive either 5HTP or a placebo during two 28-day dosing periods separated by a 3-week washout phase. The 5HTP dose is based on weight: 50mg twice daily for those under 100 lbs, and 100mg twice daily for those over 100 lbs. The study uses a randomized, triple-blind crossover design, meaning participants switch from one treatment to the other during the study. Over about 12 weeks, participants will attend five study visits where lung function tests, blood samples to measure eosinophils, and anxiety/depression questionnaires will be completed. Researchers will monitor changes in lung function, blood markers, and mental health symptoms to evaluate the effects of 5HTP. Safety assessments will ensure participant well-being throughout the study period.
CONDITIONS
Brief Title
5HTP Regulation Of Asthma In Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 8-18 Years
- Mild to Moderate Asthma based on ATS guidelines
- Positive Allergy Test (positive skin or serum IgE)
- Weight 6 70 lbs (32 kg)
- CES-DC cut-off 6 15 or SCARED cut-off 6 25
- Ability to comply with study visits and procedures
- Informed Consent by participant and if applicable the parent or legal guardian
You will not qualify if you...
- 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 safety or study data quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 11 weeks per treatment period including washout
Participants receive 28 days of either 5-hydroxytryptophan or placebo dosing based on their weight, followed by a 3-week washout period before crossing over to the other treatment arm.
Visits during dosing and washout periods as scheduled by the study
Trial Site Locations
Total: 1 location
1
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
K
Kirsten Kloepfer, MD
P
Patrick Campbell, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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