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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Xiu-Min Li
Study ID
NCT02879006
Phase
PHASE2
Status
Unknown

Conditions

  • Food Allergy

Eligibility Criteria

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

Interventions

  • Chinese Herbal Medication — DRUG
    Capsules, 26 month course, starting 2 months pre-OIT
  • Placebo — DRUG
    Placebo capsules that look identical to E-B-FAHF-2, 26 month course, starting 2 months pre-OIT
  • Omalizumab — DRUG
    4 months course, starting 2 months pre-OIT through the 2 month build-up phase
  • Multi OIT — DRUG
    24 months of multi OIT (maintenance dose of 1gm each food allergen)

Study Details

The purpose of this study is testing the use 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 31, 2016
Status verified
Aug 2020
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020

Study Design

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

Arms

  • Active Comparator: Chinese Herbal Medication
  • Placebo Comparator: Placebo

Primary Outcome Measure

Sustained unresponsiveness [ Time Frame: month 29 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University· Baltimore, MDIcahn School of Medicine at Mount Sinai· New York, NY

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