RecruitingPhase 2NCT04160910

5HTP Regulation Of Asthma In Children


Sponsor

Indiana University

Enrollment

20 participants

Start Date

Feb 11, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether 5-HTP — a natural supplement that the body uses to make serotonin — can help reduce asthma symptoms in children who also have anxiety or depression. Research suggests that mood and asthma are connected through serotonin pathways in the lungs and brain, and this study explores whether 5-HTP might address both. **You may be eligible if...** - You are between 8 and 18 years old - You have mild to moderate asthma - You have a positive allergy test (skin or blood IgE test) - You weigh at least 70 lbs (32 kg) - You score above the cutoff on a standardized anxiety or depression scale (CES-DC or SCARED) **You may NOT be eligible if...** - You are currently taking an SSRI antidepressant - You take a leukotriene inhibitor (like montelukast/Singulair) - You take a biologic medication for asthma (like omalizumab or dupilumab) - You have severe asthma - You have had a previous bad reaction to 5-HTP Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG5-Hydroxytryptophan

Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study

DRUGPlacebo

Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study


Locations(1)

Indiana University

Indianapolis, Indiana, United States

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NCT04160910