Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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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 takingSSRILeukotriene inhibitorBiologic medication
Rules you outSevere 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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
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…
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
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