Effects of Echinacea in Children

Study Overview
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Brief Summary
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The goal of the this study is to determine if Echinacea purpurea stimulates the immune system in children. For the study, 40 healthy children, 6-11 years old will be randomized to receive Echinacea purpurea or placebo for 10 days in 3 consecutive months. Blood samples will be obtained in the children just before starting study medication, during the first course of medication and either just prior to starting the second course of medication or 50 days following the last of the three courses of medication. Markers of immune activity in children receiving Echinacea or placebo will be compared.

Detailed Description
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This is an application to study the biologic activity of a specific formulation of Echinacea purpurea in children 6-11 years old. The goal of the study is to determine if Echinacea purpurea is associated with activation of immune markers including cytokines such as tumor necrosis factor alpha (TNF), interferon alpha, interferon gamma, and interleukins 2, 6, and 12 (IL-2, IL-6, and IL-12), as well CD25 and CD69 activation. A total of 40 study children will be randomized to receive either the Echinacea purpurea formulation or placebo for 10 consecutive days at the start of 3 consecutive 30-day periods. Blood samples will be obtained at baseline, at the time of peak TNF activity, and either 30 or 120 days after beginning the study medication. Prior to beginning this pediatric study peak TNF activity will be determined by administering the Echinacea purpurea to 3 adult volunteers for 10 days and doing frequent blood sampling during this period. If it is demonstrated that this formulation of E purpurea has biologic activity, a large randomized controlled trial is planned to determine if E purpurea can prevent upper respiratory tract infection (URI) in children 2-11 years old.

Official Title
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Assessing the in Vivo Effect of Echinacea Purpurea on Markers of Immune Activities in Children

Conditions
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Upper Respiratory Infections

Intervention / Treatment
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* Biological: Echinacea purpurea 100 mg/ml in liquid formulation
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children 6-11 years old Parent/Caregiver who can read and speak English One child per family Exclusion Criteria: History of allergic reaction to Echinacea or related species History of asthma History of allergic rhinitis History of autoimmune disease

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Echinacea purpurea<br> | Biological: Echinacea purpurea 100 mg/ml in liquid formulation<br>* 10 ml BID for 10 consecutive days at the start of 3 consecutive 30 day periods<br>|
| Placebo Comparator: 2. placebo<br> | Other: placebo<br>* 10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF levels |  | During first course of study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD25/CD69 activation |  | 120 days | 
| IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels |  | 120 days | 
| specific and general adverse events |  | 120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper respiratory tract infections, Children, Echinacea, Prevention, Immune modulation