5HTP for Asthma in Children

Overseen By Patrick Campbell, BS

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Indiana University

Must not be taking: SSRIs, Leukotriene inhibitors, Biologics

Disqualifiers: Severe asthma, Adverse reaction to 5HTP, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a supplement called 5-hydroxytryptophan (5HTP) can improve breathing and anxiety symptoms in children with asthma. Participants will randomly receive either the 5HTP supplement or a placebo (a harmless pill without the active supplement) and later switch between the two. The trial targets children and teens aged 8 to 18 with mild to moderate asthma and a positive allergy test. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that 5-hydroxytryptophan is likely to be safe for children with asthma?

Research has shown that 5-hydroxytryptophan (5HTP) is generally safe for people. Studies have found that 5HTP can reduce allergic lung inflammation by 70% to 90%. It works by preventing certain white blood cells, called eosinophils, from moving to the lungs, which might help with asthma symptoms. Importantly, these studies did not find major side effects related to body weight or blood tests.

While researchers continue to study 5HTP for asthma, it is a well-known supplement used for other conditions, suggesting it is somewhat safe for humans. However, since this trial is in the early stages, researchers are still collecting detailed safety information. Always consult a healthcare provider before joining any clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Unlike the standard asthma treatments, which usually include inhalers that deliver corticosteroids or bronchodilators, 5-hydroxytryptophan (5-HTP) is unique because it's a naturally occurring amino acid that can influence serotonin levels in the body. Researchers are excited about 5-HTP because it offers a potential new mechanism of action by addressing the inflammation related to asthma, possibly providing relief through a different pathway than traditional medications. This approach could mean fewer side effects compared to the long-term use of steroids, making it an attractive option for children with asthma.

What evidence suggests that 5HTP might be an effective treatment for asthma in children?

In this trial, participants will receive either 5-hydroxytryptophan (5HTP) or a placebo. Research suggests that 5HTP might reduce asthma symptoms by lowering lung inflammation. One study showed that 5HTP decreased allergic lung inflammation by 70–90%, potentially helping children with asthma breathe better. It achieves this by preventing certain white blood cells, called eosinophils, from moving into the lungs, which are involved in allergic reactions. This suggests that 5HTP might alleviate the breathing problems common in asthma. While these findings are encouraging, they primarily come from early studies, so further research is needed to confirm these effects in children with asthma. ^{1 2 3 4 5}

Who Is on the Research Team?

Kirsten Kloepfer, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11153829/

SNPs in 5-HTRs associate with asthmatic lung function Previous research showed that 5-hydroxytryptophan (5HTP), a metabolic precursor of serotonin, reduces allergic lung inflammation by inhibiting eosinophil ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04160910

NCT04160910 | 5HTP Regulation Of Asthma In Children 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3469632/

Inhibition of allergic inflammation by supplementation with 5 ... Interestingly, 5-HTP reduced allergic lung inflammation by 70–90% and reduced antigen-induced airway responsiveness without affecting body weight, blood ...

4. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/listing/10941/5htp-regulation-of-asthma/

5HTP Regulation Of Asthma In Children: A Double-Blind The purpose of this study is to learn if taking an over the counter supplement called 5-hydroxytryptophan (5HTP) can improve breathing and ...

5. frontiersin.org frontiersin.org/journals/allergy/articles/10.3389/falgy.2024.1385168/full

5-HTP inhibits eosinophilia via intracellular endothelial 5- ... 5-hydroxytryptophan (5HTP), a metabolic precursor of serotonin, reduces allergic lung inflammation by inhibiting eosinophil migration across endothelial ...