The increasing prevalence of allergic diseases in westernized countries poses a significant health problem and a tremendous burden on quality of life and healthcare expenditure. Food allergy affects as many as 6% of young children and 3% to 4% of adults. While the majority of children outgrow their allergy to milk, egg, wheat and soy, allergies to peanut, tree nuts, fish and shellfish are often life-long. Currently, there are no treatments that can cure or provide long-term remission from food allergy. Based on our preliminary studies, we hypothesize that our investigational botanical drug, FAHF-2TM, will be a safe and effective herbal therapy for food allergy. We are enrolling those age 12-45 yrs old with allergies to peanut, tree nuts, sesame, fish, and/or shellfish.
To address our hypothesis, we propose the following aims: Aim #1: To investigate the efficacy of FAHF-2TM for food allergy (in addition to current food allergen avoidance). Aim #2: To characterize the immunomodulatory effects of FAHF-2TM on food allergic patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
68
We propose to test 10 tablets administered orally three times daily (t.i.d.) for 6 months in the Phase II study. The subjects will be randomized to 1 of 2 groups; FAHF-2 or Placebo group. Both groups will undergo physician supervised Double-blinded placebo controlled food challenges, once during screening before starting treatment and again after 6 months of therapy.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
RECRUITINGMount Sinai School Medicine
New York, New York, United States
RECRUITINGSafety of FAHF-2
Time frame: 1 year
lab studies
Time frame: 1 year
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