Using 5HTP to Improve Asthma Symptoms in Children
5HTP Regulation Of Asthma In Children
This study is testing if the amino acid supplement 5HTP can help improve lung function and reduce anxiety in children with mild to moderate asthma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Drugs / interventions | omalizumab, mepolizumab, benralizumab, dupilumab |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT04160910 on ClinicalTrials.gov |
What this trial studies
This study investigates whether the amino acid supplement 5-hydroxytryptophan (5HTP) can enhance lung function and alleviate anxiety symptoms in children with mild to moderate asthma and allergic sensitization. Participants will be randomly assigned to receive either 5HTP or a placebo, with a crossover to the alternate group later in the study. The primary outcome will be measured by changes in lung function (FEV1), while secondary outcomes will assess blood eosinophil counts and anxiety/depression symptoms through questionnaires. The study spans approximately 12 weeks with five scheduled visits.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-18 with mild to moderate asthma and a positive allergy test.
Not a fit: Patients with severe asthma or those currently taking specific asthma medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, non-invasive treatment option for improving lung function and reducing anxiety in children with asthma.
How similar studies have performed: While the use of 5HTP in asthma treatment is novel, preclinical studies have shown promising results in improving lung function.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Kirsten Kloepfer, MD — Indiana University
- Study coordinator: Kirsten Kloepfer, MD
- Email: kloepfer@iu.edu
- Phone: (317) 278-7860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.