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Randomized, double‐blind, placebo‐controlled, parallel group study to evaluate the effect of 500 mg once a day EpiCor on allergy symptoms
Author(s) -
Robinson Larry E,
Moyad Mark A
Publication year - 2009
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.23.1_supplement.lb473
Subject(s) - placebo , medicine , allergy , nasal congestion , nose , randomized controlled trial , clinical trial , surgery , immunology , alternative medicine , pathology
An immunogenic fermentate product, EpiCor®, has demonstrated the ability to reduce the risk and duration of cold and flu‐like symptoms, and to modulate the immune response in two previous randomized controlled trials. In this follow‐up study, EpiCor is tested for its impact on seasonal allergies. Eighty‐four (84) healthy subjects tested positive for seasonal allergies and were randomized to 500mg/day EpiCor vs. placebo during the 12 week spring/summer allergy season. Subjects completed a questionnaire and recorded their symptoms and use of rescue medication in an allergy diary. Because pollen counts were significantly higher for weeks 0‐6 vs. weeks 7‐12 (p=0.0003), only data from the first 6 weeks of the trial are reported. During this period, EpiCor significantly reduced the mean severity of nasal symptoms (p=0.03), runny nose (p=0.005) and nasal congestion (p=0.04), and resulted in approximately 6 fewer congestive days vs. placebo (17 vs. 23 days, p=0.04). Subjects taking EpiCor also utilized significantly less rescue medication (p=0.04) vs. placebo. Nasal smear data mirrored this observed effectiveness, with lower nasal eosinophils (p<0.06) in the EpiCor vs. placebo group. These current and past clinical trials suggest that this nutritional fermentate product may have beneficial clinical immune modulating effects. Research supported by Embria Health Sciences, Ankeny, Iowa.