5HTP Regulation Of Asthma In Children

NCT ID: NCT04160910

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-11
• Study Completion Date: 2026-01-05

Brief 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.

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

Conditions

Mild or Moderate Asthma With Allergic Sensitization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

5-Hydroxytryptophan

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

5-Hydroxytryptophan

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

5HTP

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Kirsten Kloepfer

Assistant Professor of Pediatrics; Division of Pulmonary, Allergy and Sleep Medicine; Riley Hospital for Children at Indiana University Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirsten Kloepfer, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kirsten Kloepfer, MD

Role: CONTACT

kloepfer@iu.edu

(317) 278-7860

Patrick Campbell, BS

Role: CONTACT

ptc@iu.edu

(317) 278-7117

Facility Contacts

Patrick T Campbell, BS

Role: primary

ptc@iu.edu

317-278-7117

Lisa Bendy

Role: backup

lbendy@iu.edu

3172787152

Other Identifiers

Kloepfer_1902366300

Identifier Type: -

Identifier Source: org_study_id