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

Sponsor
New York Medical College
Study ID
NCT06103656
Phase
PHASE2
Status
Completed

Conditions

  • Food Allergy

Eligibility Criteria

Sex
ALL
Age
6 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 20, 2016
Status verified
Mar 2024
Primary completion
Jul 2, 2020
Completion
Feb 22, 2021

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Comparator::Chinese Herbal Medication
    Interventions: \- Drug: Chinese Herbal Medication (E-B-FAHF-2), dose level was determined using the subject's weight at the screening visit (\>20-30 kg = 5 capsules daily, \>30-70 kg = 8 capsules daily, and \>70 kg = 10 capsules daily)
  • Placebo Comparator: Placebo Comparator: Placebo
    Interventions: * Drug: Placebo. Placebo capsules were identical in appearance but contained corn starch * Drug: Omalizumab. Omalizumab was dosed as per the product insert * Drug: Multi OIT. An initial rush dose to a maximum of 250 mg of protein of each allergen (total 270 mg of protein) and up-dosing every 2 weeks until the maintenance dose of 1000mg was reached.

Primary Outcome Measure

Sustained unresponsiveness to cumulative dose of 4,444 mg protein [ Time Frame: 29 months ]

Related Studies