5HTP for Asthma in Children
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.12345Why 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.12345
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 5HTP or placebo to assess changes in lung function and anxiety symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Active Control
Placebo Group
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
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:
- Anxiety
- ADHD
- Insomnia
- Headache
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Citations
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 ...
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 ...
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-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 ...
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