5HTP for Mild or Moderate Asthma in Children

5HTP Regulation Of Asthma In Children

Recruiting Phase 2 Interventional Study
Mild or Moderate Asthma With Allergic Sensitization
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
8 – 18
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Indiana University · Other
Who this trial is looking for

This trial is looking for children aged 8-18 with mild or moderate asthma to see if a supplement called 5HTP can help with breathing and anxiety. Participants will take either 5HTP or a placebo, and there will be five visits over about 12 weeks.

Are You a Good Fit for This Trial?
Must not be taking SSRILeukotriene inhibitorBiologic medication
Rules you out Severe asthma

You may be able to join if

  • I am between 8 and 18 years old
  • I have mild to moderate asthma
  • I have a positive allergy test
  • I weigh at least 70 lbs
  • I have a CES-DC score of 15 or higher or a SCARED score of 25 or higher
  • I can attend study visits and follow study procedures
  • I or my parent/guardian can give informed consent

You may not be able to join if

  • I am currently taking an SSRI
  • I am taking a leukotriene inhibitor
  • I have severe asthma
  • I am taking a biologic medication
  • I have a medical history of an adverse reaction to 5HTP
  • I have physical issues that could affect my safety or the study

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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.Th…
Trial Locations
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Eligibility Criteria
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 co…
Contacts

Kirsten Kloepfer, MD

(317) 278-7860

kloepfer@iu.edu

CONTACT

Lisa Bendy, MBA

(317) 278-7218

lbendy@iu.edu

CONTACT