5HTP Regulation Of Asthma In Children
Primary Purpose
Mild or Moderate Asthma With Allergic Sensitization
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
5-Hydroxytryptophan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mild or Moderate Asthma With Allergic Sensitization
Eligibility Criteria
Inclusion Criteria:
- Age 8-17 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
Sites / Locations
- Indiana UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
5-hydroxytryptophan
Placebo
Arm Description
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
Outcomes
Primary Outcome Measures
Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1)
Pulmonary function testing will be performed at Baseline, Day 28, and Day 49, and Day 77
Secondary Outcome Measures
Blood will be obtained to assess Eosinophil Count
Will be performed at Baseline, Day 28, and Day 49, and Day 77
Questionnaires will be utilized to look for a decrease in symptoms for Anxiety/Depression Reduced Symptoms for Anxiety/Depression
Changes in Anxiety/Depression will be determined via questionnaire that will be administered at Baseline, Day 28, and Day 49, and Day 77 . Will use the Center for Epidemiological Studies Depression Scale for Children (CES-DC) to measure depression and Screen for Child Anxiety Related Disorders (SCARED)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04160910
Brief Title
5HTP Regulation Of Asthma In Children
Official Title
5HTP Regulation Of Asthma In Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The objective of this study is to test the hypothesis that over-the-counter amino acid supplement 5HTP (isolated from the plant Griffonia Simplifolia) reduces human allergic lung responses and consequently improves lung function. The primary outcome is the change in FEV1. We anticipate the 5HTP at the proposed doses will improve lung function as in preclinical studies that used clinically relevant 5HTP. Secondary outcomes will be blood eosinophil counts and reduced symptoms for anxiety/depression, as seen in changes in the anxiety-depression scores from questionnaires (CES-DC & SCARED). The results from these studies have the transformative potential to influence approaches to improve lung function and asthma-associated anxiety/depression.
Aim 1: Test that 5HTP improves lung function in children with allergic asthma
Aim 2: Test that 5HTP reduces eosinophil numbers in the blood and nasal fluid of patients with asthma from Aim 1
Aim 3: Test that 5HTP decreases lung inflammation, increases cortisol and prolactin without altering systemic plasma concentrations of 5HTP, serotonin, 5-hydroxyindoleacetic acid (5-HIAA), and dopamine
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild or Moderate Asthma With Allergic Sensitization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
5-hydroxytryptophan
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
5-Hydroxytryptophan
Other Intervention Name(s)
5HTP
Intervention Description
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
Primary Outcome Measure Information:
Title
Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1)
Description
Pulmonary function testing will be performed at Baseline, Day 28, and Day 49, and Day 77
Time Frame
77 days
Secondary Outcome Measure Information:
Title
Blood will be obtained to assess Eosinophil Count
Description
Will be performed at Baseline, Day 28, and Day 49, and Day 77
Time Frame
77 days
Title
Questionnaires will be utilized to look for a decrease in symptoms for Anxiety/Depression Reduced Symptoms for Anxiety/Depression
Description
Changes in Anxiety/Depression will be determined via questionnaire that will be administered at Baseline, Day 28, and Day 49, and Day 77 . Will use the Center for Epidemiological Studies Depression Scale for Children (CES-DC) to measure depression and Screen for Child Anxiety Related Disorders (SCARED)
Time Frame
77 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten Kloepfer, MD
Phone
(317) 278-7860
Email
kloepfer@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Campbell, BS
Phone
(317) 278-7117
Email
ptc@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Kloepfer, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick T Campbell, BS
Phone
317-278-7117
Email
ptc@iu.edu
First Name & Middle Initial & Last Name & Degree
Lisa Bendy
Phone
3172787152
Email
lbendy@iu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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5HTP Regulation Of Asthma In Children
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