RecruitingPhase 2

5HTP Regulation Of Asthma In Children

United States20 participantsStarted 2021-02-11

Plain-language 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.

Who can participate

Age range8 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 77 days

Trial details

NCT IDNCT04160910

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Kirsten Kloepfer, MD

(317) 278-7860 kloepfer@iu.edu