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The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults

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ClinicalTrials.gov Identifier: NCT03361072
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Paula Kauppi, MD, PhD, Helsinki University Central Hospital

Study Description
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Brief Summary:
The aim is to analyse the results of per oral immunotherapy treatment in severe milk, peanut or egg allergy in adults. This is the second part of the oral immunotherapy study in adults at Skin and Allergy Hospital. The diagnosis of food allergy is verified with positive history, skin prick tests, egg and milk allergen specific IgE (immunoglobulin E) antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. OIT (oral immunotherapy) is performed according to a detailed plan. Lung function parameters are followed before OIT and and a year after OIT.

Condition or disease Intervention/treatment Phase
Food Allergy Dietary Supplement: Oral immunotherapy Not Applicable

Detailed Description:
30 patients with milk allergy (at least 18 year olds), 30 patients with peanut allergy and 30 patients with egg allergy are treated with OIT. The diagnosis of food allergy is verified with positive history, skin prick test, egg and milk allergen specific IgE antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. Quality of life, anxiety and patient history data is collected by questionnaires. All the patients undergo a spirometry with a bronchodilatator test, exhaled nitric oxide test and a methacholine challenge before and a year after oral immunotherapy. All the patients undergoing oral immunotherapy are prescribed with emergency medication such as antihistamine tablets, prednisolon tablets (40mg for three days in adults), epinephrine autoinjector (300 µg per dose) and salbutamol or terbutaline inhalator.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective open label study on oral immunotherapy with either milk, or peanut or egg white food products.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Per Oral Immunotherapy Treatment in Severe IgE Mediated Milk, Peanut and Egg Allergy in Adults
Actual Study Start Date : August 3, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Milk allergy
Milk oral immunotherapy intervention for milk allergy
 Dietary Supplement: Oral immunotherapy
Milk, peanut or egg oral immunotherapy
Experimental: Peanut allergy
Peanut oral immunotherapy intervention for peanut allergy
 Dietary Supplement: Oral immunotherapy
Milk, peanut or egg oral immunotherapy
Experimental: Egg allergy
Egg oral immunotherapy intervention for egg allergy
 Dietary Supplement: Oral immunotherapy
Milk, peanut or egg oral immunotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Desensitisation [ Time Frame: 1 year, through study completion ]
    Increase in tolerated dose of food compared to the pre-OIT, number of participants


Secondary Outcome Measures :
  1. Decrease in worries associated with food allergy [ Time Frame: 1 year, through study completion ]
    Quality of life and reported concerns and worries associated with food allergy using a VAS scale (visual analogue scale) from 0 (no worries) to 100 mm (maximal worries) before OIT and at one year after OIT


Other Outcome Measures:
  1. Number of participants with treatment-related adverse events [ Time Frame: 1 year, through study completion ]
    Follow-up of safety of OIT

  2. Decrease in allergen specific IgE values [ Time Frame: 1 year, through study completion ]
    Decrease in allergen specific IgE values


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • severe milk, peanut or egg allergy verified with positive symptom history, skin prick tests and serum IgE tests and a challenge test

Exclusion Criteria:

  • instable cerebrovascular or heart disease, active autoimmune disease or cancer, or current use of betablockers.
  • poorly controlled asthma or FEV1 < 70% (FEV1< -2SD)
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03361072


Contacts
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Contact: Paula Kauppi, MD, PhD +358504286802 paula.kauppi@hus.fi

Locations
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Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029
Contact: Paula M Kauppi       paula.kauppi@hus.fi   
Contact: Mika J Mäkelä       mika.makela@hus.fi   
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Paula Kauppi, MD, PhD Helsinki University Central Hospital
More Information
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Responsible Party: Paula Kauppi, MD, PhD, MD, PhD, Chief Specialist, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03361072    
Other Study ID Numbers: HUS/486/2017
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paula Kauppi, MD, PhD, Helsinki University Central Hospital:
oral immunotherapy
milk
peanut
egg
adult
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Egg Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate