E-B-FAHF-2, Multi OIT and Xolair for Food Allergy (NCT06103656) | Clinical Trial Compass
CompletedPhase 2
E-B-FAHF-2, Multi OIT and Xolair for Food Allergy
33 participantsStarted 2016-08-20
Plain-language summary
The purpose of this study is testing the use of Enhanced-Butanol purified-Food Allergy Herbal Formula-2 (E-B-FAHF-2) Chinese herbal therapy in combination with multi-food oral immunotherapy (OIT) and Xolair® (Omalizumab) to help children and adults who are allergic to foods be able to safely tolerate food allergens. Specifically in this protocol, the food allergens are milk, egg, peanut, almond, cashew, hazelnut, walnut, sesame, and/or wheat. Omalizumab is considered an investigational drug for the treatment of food allergies in children and adults. Investigational means it has not been approved by the Food and Drug Administration (FDA) for use in the U.S. The researchers hope to learn whether the addition of Chinese herbal therapy (E-B-FAHF-2) can improve the outcome of sustained unresponsiveness (which is the ability to consume a food allergen and pass an oral food challenge after being off treatment for 3 months) as compared to placebo (i.e. subjects with OIT/Omalizumab + herbal vs. OIT/Omalizumab + placebo), and will help adults and children be able to safely ingest the foods they are allergic to.
Who can participate
Age range6 Years – 40 Years
SexALL
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Inclusion Criteria:
* 6 through 40 years
* At least one of the following for each of the 3 study allergens: serum immunoglobulin E (IgE) \>4000 U/L or skin -prick test \>6mm
* dose limiting symptoms at a cumulative dose of \<=444 mg protein for 3 allergens as screening double-blind, placebo-controlled food challenge
* use of an effective method of contraception by females of child-bearing potential
* ability to ingest oat or corn with no allergic reaction
Exclusion Criteria:
* If baked milk or egg are tolerated (assessed by clinical report), then milk or egg may not be included as a study allergen
* Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, and serious ventricular arrhythmias
* History of other chronic disease requiring therapy (other than asthma, atopic dermatitis, or rhinitis)
* History of eosinophilic gastrointestinal disease
* Current participation in any other interventional study
* Investigational drug use within 90 days
* Subject is on build-up phase of any allergen immunotherapy (prior to maintenance dosing)
* Current uncontrolled moderate to severe asthma as defined by:
* Forced Expiratory Volume-1 (FEV1) value \<80% predicted or any clinical features of moderate or severe persistent asthma baseline severity (as defined by the 2007 NHLBI Guidelines) and greater than high daily doses of inhaled corticosteroids (as defined for children and adults using dosing tables from the 2007 NHLBI Guidelines…
What they're measuring
1
Sustained unresponsiveness to cumulative dose of 4,444 mg protein