5HTP Regulation Of Asthma In Children

Mild or Moderate Asthma With Allergic Sensitization Clinical Trial

Official title:

5HTP Regulation Of Asthma In Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04160910
• Other study ID #: Kloepfer_1902366300
• Status: Recruiting
• Phase: Phase 2
• Start date: February 11, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Indiana University
• Contact: Kirsten Kloepfer, MD
• Phone: (317) 278-7860
• Email: kloepfer[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Mild or Moderate Asthma With Allergic Sensitization

Intervention

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

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1)	Pulmonary function testing will be performed at Baseline, Day 28, and Day 49, and Day 77	77 days
Secondary	Blood will be obtained to assess Eosinophil Count	Will be performed at Baseline, Day 28, and Day 49, and Day 77	77 days
Secondary	Questionnaires will be utilized to look for a decrease in symptoms for Anxiety/Depression Reduced Symptoms for Anxiety/Depression	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)	77 days