RightFit
RecruitingPhase 2

5HTP Regulation Of Asthma In Children

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
8 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Later in the study subjects will crossover to the other group.There are 5 study visits over the course of about 12 weeks."
  • "Secondary outcomes will be blood eosinophil counts and reduced symptoms for anxiety/depression, as seen in changes in the anxiety-depression scores from questionnaires (CES-DC \& SCARED)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a supplement called 5HTP can improve breathing and anxiety symptoms in children ages 8–18 with asthma. Participants start with either 5HTP or a placebo (a pill with no active supplement), chosen by chance, then switch to the other group. There are 5 study visits over about 12 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 8–18 years old.
  • Have mild to moderate asthma based on medical guidelines.
  • Have a positive allergy test from a skin or blood test.
  • Weigh at least 70 pounds (32 kilograms).
  • Have a score of at least 15 on the CES-DC depression survey or meet the listed SCARED anxiety survey cutoff of 25.
  • Be able to follow study steps and attend visits.
  • Agree to take part, with a parent or legal guardian's consent if needed.

Who can't join

  • Currently take an SSRI, a type of medicine used for depression or anxiety.
  • Take a leukotriene inhibitor, an asthma medicine such as montelukast or Zileuton.
  • Have severe asthma based on medical guidelines.
  • Take a biologic medicine, such as omalizumab, mepolizumab, benralizumab, or dupilumab.
  • Have had a bad reaction to 5HTP.
  • Have findings on a physical exam that could make the study unsafe or make the results less reliable.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (1)

IN