5HTP regulering af astma hos børn
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Kirsten Kloepfer, MD
- Telefonnummer: (317) 278-7860
- E-mail: kloepfer@iu.edu
Undersøgelse Kontakt Backup
- Navn: Lisa Bendy, MBA
- Telefonnummer: (317) 278-7218
- E-mail: lbendy@iu.edu
Studiesteder
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- Indiana University
-
Kontakt:
- Lisa Bendy, MBA
- Telefonnummer: 317-278-7152
- E-mail: lbendy@iu.edu
-
Kontakt:
- Lisa Bendy, MBA
- Telefonnummer: 3172787152
- E-mail: lbendy@iu.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 5-hydroxytryptophan
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 |
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
Andre navne:
|
|
Placebo komparator: Placebo
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 |
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1)
Tidsramme: 77 days
|
Pulmonary function testing will be performed at Baseline, Day 28, and Day 49, and Day 77 |
77 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood will be obtained to assess Eosinophil Count
Tidsramme: 77 days
|
Will be performed at Baseline, Day 28, and Day 49, and Day 77 |
77 days
|
|
Questionnaires will be utilized to look for a decrease in symptoms for Anxiety/Depression Reduced Symptoms for Anxiety/Depression
Tidsramme: 77 days
|
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) |
77 days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Kirsten Kloepfer, MD, Indiana University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Lymfesygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Hemiske og lymfatiske sygdomme
- Lymfom, follikulært
- Aminosyrer, peptider og proteiner
- Aminosyrer
- Aminosyrer, aromatisk
- Aminosyrer, cykliske
- Tryptophan
- 5-hydroxytryptophan
Andre undersøgelses-id-numre
- Kloepfer_1902366300
Plan for individuelle deltagerdata (IPD)
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