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Trial record 3 of 340 for:    "Food Allergy"

Registry of Food Allergy Oral Immunotherapy Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03059589
Recruitment Status : Enrolling by invitation
First Posted : February 23, 2017
Last Update Posted : February 18, 2019
Information provided by (Responsible Party):
Food Allergy Support Team

Brief Summary:
The purpose of this patient registry is to demonstrate safety and efficacy of food oral immunotherapy in food allergic patients. Factors that lead to adverse reactions will be identified. The frequency of rescue epinephrine use will be recorded.

Condition or disease
Food Allergy

Detailed Description:
Each participating US clinic is assigned a site number and patients starting food oral immunotherapy will be given a four digit number starting at 0001 within each site. All data will be collected and reported electronically at each clinical site.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: National Registry of Food Allergy Treatment
Actual Study Start Date : April 15, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. efficacy of food allergy treatment [ Time Frame: 3 years ]
    the percentage of patients who successfully reach the maintenance dose of food

Secondary Outcome Measures :
  1. epinephrine use [ Time Frame: 3 years ]
    The frequency of epinephrine use during the course of oral immunotherapy as reported in the prospective database. Also, identify factors that are associated with the need for epinephrine.

  2. factors associated with the failure to reach the target dose of food ingestion [ Time Frame: 3 years ]
    Identify factors that are associated with treatment failures through analysis of patient demographics, baseline laboratory test results, and concomitant atopic conditions.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to participating clinical sites with high probability of food allergy who choose to undergo food oral immunotherapy treatment.

Inclusion Criteria:

  • a history of an allergic reaction following exposure to the food and positive in-vivo or in-vitro sensitivity testing to the food,
  • no prior exposure to the food, but markedly high in-vitro specific immunoglobulin E (IgE) to the food

Exclusion Criteria:

  • pregnancy
  • severe asthma
  • poorly controlled atopic dermatitis
  • eosinophilic esophagitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03059589

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United States, Florida
Food Allergy Center of FL
Sarasota, Florida, United States, 34239
Sponsors and Collaborators
Food Allergy Support Team
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Principal Investigator: Hugh Windom, MD

Additional Information:

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Responsible Party: Food Allergy Support Team Identifier: NCT03059589     History of Changes
Other Study ID Numbers: Mylan-16-004
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Food Allergy Support Team:
food anaphylaxis
peanut anaphylaxis
food oral immunotherapy
food allergy
food allergy treatment

Additional relevant MeSH terms:
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Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate