Recruiting
Phase 2

5HTP

Sponsor:

Indiana University

Code:

NCT04160910

Conditions

Mild or Moderate Asthma With Allergic Sensitization

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

5-Hydroxytryptophan

Placebo

Study Details

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

Study ID

NCT04160910

Start date

Feb 11, 2021

Status verified date

Feb, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

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

Primary outcome measure

  • Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1) [ Time Frame: 77 days ]

Central Contacts and Locations

Central contacts

Kirsten Kloepfer, MD

(317) 278-7860kloepfer@iu.edu

Patrick Campbell, BS

(317) 278-7117ptc@iu.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Patrick T Campbell, BS

317-278-7117ptc@iu.edu

Lisa Bendy

3172787152lbendy@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-03-02.