Using 5HTP to Improve Asthma Symptoms in Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether the amino acid supplement 5-hydroxytryptophan (5HTP) can enhance lung function and alleviate anxiety symptoms in children with mild to moderate asthma and allergic sensitization. Participants will be randomly assigned to receive either 5HTP or a placebo, with a crossover to the alternate group later in the study. The primary outcome will be measured by changes in lung function (FEV1), while secondary outcomes will assess blood eosinophil counts and anxiety/depression symptoms through questionnaires. The study spans approximately 12 weeks with five scheduled visits.

Why it matters

Who can join: the full rules

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

Where it's running

• Indiana University
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Kirsten Kloepfer, MD — Indiana University
• Study coordinator: Kirsten Kloepfer, MD
• Email: kloepfer@iu.edu
• Phone: (317) 278-7860

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.