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Recruiting NCT04160910

5HTP Regulation Of Asthma In Children

Phase II Interventional Mild or Moderate Asthma With Allergic Sensitization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 5-Hydroxytryptophan, Placebo.
Who it may be relevant to
Registry conditions: Mild or Moderate Asthma With Allergic Sensitization. Basic parameters: 8 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

The objective of this study is to test the hypothesis that over-the-counter amino acid supplement 5HTP (isolated from the plant Griffonia Simplifolia) reduces human allergic lung responses and consequently improves lung function. The primary outcome is the change in FEV1. We anticipate the 5HTP at the proposed doses will improve lung function as in preclinical studies that used clinically relevant 5HTP. 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). The results from these studies have the transformative potential to influence approaches to improve lung function and asthma-associated anxiety/depression.

* Aim 1: Test that 5HTP improves lung function in children with allergic asthma * Aim 2: Test that 5HTP reduces eosinophil numbers in the blood and nasal fluid of patients with asthma from Aim 1 * Aim 3: Test that 5HTP decreases lung inflammation, increases cortisol and prolactin without altering systemic plasma concentrations of 5HTP, serotonin, 5-hydroxyindoleacetic acid (5-HIAA), and dopamine

Interventions

  • Drug 5-Hydroxytryptophan
    Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
  • Drug Placebo
    Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study

Primary outcome measures

  • Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1) [Time frame: 77 days]
Secondary outcome measures (2)
  • Blood will be obtained to assess Eosinophil Count [Time frame: 77 days]
  • Questionnaires will be utilized to look for a decrease in symptoms for Anxiety/Depression Reduced Symptoms for Anxiety/Depression [Time frame: 77 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Indiana University — Indianapolis

Identifiers

NCT: NCT04160910 · Kloepfer_1902366300

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗