5HTP Regulation Of Asthma In Children

NCT04160910 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Kloepfer_1902366300
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild or Moderate Asthma With Allergic Sensitization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Blood will be obtained to assess Eosinophil Count

  77 days

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

  77 days

Study Arms (2)

5-hydroxytryptophan

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

5-Hydroxytryptophan DRUG

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

Also known as: 5HTP

5-hydroxytryptophan

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

5-Hydroxytryptophan

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tryptophan; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kirsten Kloepfer, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten Kloepfer, MD

CONTACT

(317) 278-7860; kloepfer@iu.edu

Patrick Campbell, BS

CONTACT

(317) 278-7117; ptc@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics; Division of Pulmonary, Allergy and Sleep Medicine; Riley Hospital for Children at Indiana University Health

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 13, 2019
• Study Start: February 11, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)