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 range
6 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sustained unresponsiveness to cumulative dose of 4,444 mg protein