Actively Recruiting

Phase 2
Age: 8Years - 18Years
All Genders
NCT04160910

5HTP Regulation Of Asthma In Children

Led by Indiana University · Updated on 2026-03-02

20

Participants Needed

1

Research Sites

280 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

5HTP Regulation Of Asthma In Children

Who Can Participate

Age: 8Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 8 to 18 years
  • Mild to moderate asthma based on ATS guidelines
  • Positive allergy test (skin or serum IgE)
  • Weight at least 70 lbs (32 kg)
  • CES-DC score of 15 or higher or SCARED score of 25 or higher
  • Ability to comply with study visits and procedures
  • Informed consent by participant and parent or legal guardian if applicable
Not Eligible

You will not qualify if you...

  • Currently taking selective serotonin reuptake inhibitors (SSRIs)
  • Taking leukotriene inhibitors such as montelukast or Zileuton
  • Severe asthma based on ATS guidelines
  • Taking biologic medications like omalizumab, mepolizumab, benralizumab, or dupilumab
  • History of adverse reaction to 5HTP
  • Physical findings that would compromise study safety or data quality

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Indiana University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

K

Kirsten Kloepfer, MD

CONTACT

P

Patrick Campbell, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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5HTP Regulation Of Asthma In Children | DecenTrialz