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5HTP for Asthma in Children

This study is looking into whether a supplement called 5-hydroxytryptophan (5HTP) can help improve breathing and anxiety in children aged 8 to 18 who have mild to moderate asthma and allergies. You would either receive 5HTP or a placebo (an inactive substance), and then switch to the other treatment later. The main goal is to see if 5HTP changes your lung function, specifically your Forced Expiratory Volume at one second (FEV1), which measures how much air you can exhale in one second. The study is currently unclear about its status and plans to enroll 20 participants.

Study design
This is an interventional, double-blinded, placebo-controlled study with a crossover design, meaning participants will receive both 5HTP and placebo at different times. It plans to enroll 20 participants.
What's involved
You would have 5 study visits over about 12 weeks. This includes a 28-day period taking either 5HTP or placebo, followed by a 3-week break, and then switching to the other treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for lung function (FEV1) will be measured at 77 days.

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NCT04160910

5HTP Regulation Of Asthma In Children

Recruiting
PHASE2Ages 8–18InterventionalTreatment
Indiana University
~20 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:5-HydroxytryptophanPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1)
Measured over 77 days

Conditions

Mild or Moderate Asthma With Allergic Sensitization

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Asthma

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Kirsten Kloepfer, MD · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

Kirsten Kloepfer, MD
[email protected]
(317) 278-7860
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1)77 days

    Pulmonary function testing will be performed at Baseline, Day 28, and Day 49, and Day 77