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.

Study Overview

• Status: Recruiting
• Conditions: Mild or Moderate Asthma With Allergic Sensitization
• Intervention / Treatment: Drug: 5-Hydroxytryptophan; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kirsten Kloepfer, MD; Phone Number: (317) 278-7860; Email: kloepfer@iu.edu
• Study Contact Backup: Name: Patrick Campbell, BS; Phone Number: (317) 278-7117; Email: ptc@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
      • Contact: Patrick T Campbell, BS; Phone Number: 317-278-7117; Email: ptc@iu.edu
      • Contact: Lisa Bendy; Phone Number: 3172787152; Email: lbendy@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5-hydroxytryptophan; Dosage of 5-hydroxytryptophan will be determined by weight: If subject weighs less than 100lbs: 50mg twice a day If subject weights more than 100lbs: 100mg twice a day	Drug: 5-Hydroxytryptophan; 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 Comparator: Placebo; Dosage of placebo will be determined by weight: If subject weighs less than 100lbs: 50mg twice a day If subject weights more than 100lbs: 100mg twice a day	Drug: Placebo; Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood will be obtained to assess Eosinophil Count	Will be performed at Baseline, Day 28, and Day 49, and Day 77	77 days
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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Kirsten Kloepfer, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Follicular; Amino Acids, Peptides, and Proteins; Amino Acids; Amino Acids, Aromatic; Amino Acids, Cyclic; Tryptophan; 5-Hydroxytryptophan
• Other Study ID Numbers: Kloepfer_1902366300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes