Recruiting

5HTP Regulation Of Asthma In Children

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.

ClinicalTrials.gov IDNCT04160910

PhasePHASE2

Enrollment20

SponsorIndiana University

Age8 Years – 18 Years

SexALL

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Conditions studied

Mild or Moderate Asthma With Allergic Sensitization

About this study

Interventions

Drug: 5-Hydroxytryptophan — Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
Drug: Placebo — Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study

Primary outcomes

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

Eligibility information

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

Study locations

Indiana University, Indianapolis, Indiana 46202 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-27.