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5HTP for Asthma in Children

Phase 2

Recruiting

Led By Kirsten Kloepfer, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 77 days

Awards & highlights

Study Summary

This trial is to study the effects of 5HTP on breathing and anxiety symptoms related to asthma. Subjects will be randomly assigned to take 5HTP or a placebo, then will switch at the halfway point. There are 5 study visits over 12 weeks.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of taking 5HTP may include gastrointestinal issues like nausea or diarrhea, dizziness, sleepiness, muscle problems, or mood changes. The severity of these side effects can vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 77 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~77 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 77 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1)

Secondary outcome measures

Blood will be obtained to assess Eosinophil Count

Anxiety

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 5-hydroxytryptophanActive Control1 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: PlaceboPlacebo Group1 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,742 Total Patients Enrolled

Kirsten Kloepfer, MDPrincipal InvestigatorIndiana University

1 Previous Clinical Trials

180 Total Patients Enrolled

Media Library

5-Hydroxytryptophan (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04160910 — Phase 2

Allergic Asthma Research Study Groups: Placebo, 5-hydroxytryptophan

Allergic Asthma Clinical Trial 2023: 5-Hydroxytryptophan Highlights & Side Effects. Trial Name: NCT04160910 — Phase 2

5-Hydroxytryptophan (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04160910 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study open to senior citizens as participants?

"This clinical trial requires prospective participants to be between the ages of 8 and 17. There are 112 trials specifically aimed at youths below 18 years old, as well as 198 for those above 65."

Answered by AI

Might I have the opportunity to join this research endeavor?

"This trial requires that applicants have a diagnosis of asthma, are aged between 8 and 17 years old, and out of the 20 total participants being recruited."

Answered by AI

Has the Federal Drug Administration sanctioned 5-hydroxytryptophan for clinical use?

"There exists some evidence for 5-hydroxytryptophan's safety, so it was rated a 2 on our scale. Unfortunately there is no efficacy data at this stage of the clinical trial."

Answered by AI

Are there any opportunities to join this clinical exploration?

"This clinical trial, which was initially posted on September 12th 2019, is currently in the process of finding participants. The details have been recently updated as of January 20th 2022 according to information found through clinicaltrials.gov."

Answered by AI

How many participants have been recruited to this trial?

"Affirmative. Clinicaltrials.gov discloses that this research initiative, which was initially announced on September 12th 2019, is still recruiting participants. Around 20 subjects need to be enrolled from a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

5HTP Regulation Of Asthma In Children

Kirsten Kloepfer 2021. "5HTP Regulation Of Asthma In Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04160910.