5HTP for Asthma in Children

Overseen By Patrick Campbell, BS

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Indiana University

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 11 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are currently taking an SSRI (a type of antidepressant), a leukotriene inhibitor (like montelukast or Zileuton), or a biologic medication (such as omalizumab, mepolizumab, benralizumab, or dupilumab), you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the drug 5-HTP for asthma in children?

Research shows that 5-HTP, when combined with carbidopa, can effectively increase serotonin levels in the brain, which may have potential benefits for conditions related to serotonin imbalance. However, there is no direct evidence supporting its effectiveness for asthma in children. ^{1 2 3 4 5}

How does the drug 5-HTP differ from other asthma treatments for children?

5-HTP is unique because it targets serotonin levels, which are often elevated in children with asthma, potentially affecting their symptoms. Unlike traditional asthma treatments that focus on reducing inflammation or opening airways, 5-HTP may work by modifying serotonin, a neurotransmitter that can influence both asthma symptoms and psychological conditions. ^{6 7 8 9 10}

Research Team

Kirsten Kloepfer, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for children aged 8-18 with mild to moderate allergic asthma, weighing at least 70 lbs. They must have a positive allergy test and be able to follow the study's procedures. Kids taking certain asthma medications or with severe asthma, adverse reactions to 5HTP, or on SSRIs cannot participate.

Inclusion Criteria

Positive Allergy Test (positive skin or serum IgE)

I weigh at least 70 pounds (32 kg).

My asthma is classified as mild to moderate.

Exclusion Criteria

I have severe asthma according to ATS guidelines.

Physical findings that would compromise the safety of the study or the quality of the study data

Medical History of Adverse Reaction to 5HTP

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 5HTP or placebo to assess changes in lung function and anxiety symptoms

11 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 5-Hydroxytryptophan
• Placebo

Trial Overview The study tests if the supplement 5-hydroxytryptophan (5HTP) can help manage breathing and anxiety in asthmatic kids compared to a placebo. Participants are randomly assigned to one group then switch midway through the study, which spans roughly 12 weeks across five visits.

Participant Groups

Group I: 5-hydroxytryptophan Active Control 1 Intervention

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 II: Placebo Placebo Group 1 Intervention

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

5-Hydroxytryptophan is already approved in United States for the following indications:

Approved in United States as 5-HTP for:

• Anxiety
• ADHD
• Insomnia
• Headache

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Placebo-controlled comparison of three dose-regimens of 5-hydroxytryptophan challenge test in healthy volunteers. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Pharmacology of rising oral doses of 5-hydroxytryptophan with carbidopa. [2013]

3. Ireland pubmed.ncbi.nlm.nih.gov

Mood elevation and pituitary stimulation after i.v. l-5-HTP in normal subjects: Evidence for a common serotoninergic mechanism. [2019]

4. Austria pubmed.ncbi.nlm.nih.gov

Acute tryptophan depletion in accordance with body weight: influx of amino acids across the blood-brain barrier. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Tetrahydropterin therapy for hyperphenylalaninemia caused by defective synthesis of tetrahydrobiopterin. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Neuropharmacologic treatment of bronchial asthma with the antidepressant tianeptine: a double-blind, crossover placebo-controlled study. [2014]

7. England pubmed.ncbi.nlm.nih.gov

The effect of inhaled 5-hydroxytryptamine (5-HT, serotonin) on airway calibre in man. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The serotonin uptake-enhancing drug tianeptine suppresses asthmatic symptoms in children: a double-blind, crossover, placebo-controlled study. [2019]

9. England pubmed.ncbi.nlm.nih.gov

5-HT modifiers as a potential treatment of asthma. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Asthma medication may influence the psychological functioning of children. [2022]