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NCT Number: NCT04160910

5HTP Regulation Of Asthma In Children

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.

Recruiting

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-Hydroxytryptophan

Drug

Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study

Other names: 5HTP

Placebo

Drug

Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study

Primary outcomes

  1. Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1)

    Time frame: 77 days

    Pulmonary function testing will be performed at Baseline, Day 28, and Day 49, and Day 77

Secondary outcomes

  1. Blood will be obtained to assess Eosinophil Count

    Time frame: 77 days

    Will be performed at Baseline, Day 28, and Day 49, and Day 77

  2. Questionnaires will be utilized to look for a decrease in symptoms for Anxiety/Depression Reduced Symptoms for Anxiety/Depression

    Time frame: 77 days

    Changes in Anxiety/Depression will be determined via questionnaire that will be administered at Baseline, Day 28, and Day 49, and Day 77 . Will use the Center for Epidemiological Studies Depression Scale for Children (CES-DC) to measure depression and Screen for Child Anxiety Related Disorders (SCARED)

Study contacts

Contact information is provided by the study sponsor or research team.

Kirsten Kloepfer, MD

CONTACT

[email protected]

(317) 278-7860

Patrick Campbell, BS

CONTACT

[email protected]

(317) 278-7117

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2019
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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