NCT06103656

E-B-FAHF-2, Multi OIT and Xolair for Food Allergy

Double-Blind, Placebo-Controlled Phase 2 Study to Assess Safety and Efficacy of Chinese Herbal Therapy and Multiple Food Allergen Oral Immunotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: New York Medical College · Academic / Other
• Sex: All
• Age: 6 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prior studies have shown that this Chinese herbal formulation is safe and well-tolerated in food allergic individuals. While oral immunotherapy (OIT) can lead to desensitization, it remains uncertain whether this treatment can lead to lasting protection. Therefore, this study aims to use the Chinese herbal formula in combination with OIT to determine whether sustained protection can be achieved. All subjects will receive multi-allergen OIT, along with a 4 month course of omalizumab to provide added safety for the initial dose escalation and build up phases. Subjects will be randomized to receive active Chinese herbal formula or placebo. Subjects will be treated with OIT for 2 years and then food challenges will be performed to assess for desensitization. For those who achieve desensitization, all treatments will be discontinued and food challenges will be performed 3 months later to assess for sustained unresponsiveness.

Conditions

• Food Allergy

Interventions

Type	Name	Description
DRUG	Drug: Chinese Herbal Medication	Capsules, 26 month course, starting 2 months pre-OIT.
DRUG	Drug: Placebo	Placebo capsules that look identical to E-B-FAHF-2 containing corn starch, 26 month course, starting 2 months pre-OIT
DRUG	Drug: Omalizumab	4 months course, starting 2 months pre-OIT through the 2 month build-up phase

Timeline

• Start date: 2016-08-20
• Primary completion: 2020-07-02
• Completion: 2021-02-22
• First posted: 2023-10-27
• Last updated: 2024-03-25

Regulatory

• FDA-regulated drug study