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

This study is currently recruiting participants.
Verified November 2017 by Paula Kauppi, MD, PhD, Helsinki University Central Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03361072
First Posted: December 4, 2017
Last Update Posted: December 4, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Paula Kauppi, MD, PhD, Helsinki University Central Hospital
  Purpose
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 Intervention
Food Allergy Dietary Supplement: Oral immunotherapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Paula Kauppi, MD, PhD, Helsinki University Central Hospital:

Primary Outcome Measures:
  • 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:
  • 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 0-100 mm


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

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


Estimated Enrollment: 100
Actual Study Start Date: August 3, 2017
Estimated Study Completion Date: December 31, 2022
Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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
Contact: Paula Kauppi, MD, PhD +358504286802 paula.kauppi@hus.fi

Locations
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
Principal Investigator: Paula Kauppi, MD, PhD Helsinki University Central Hospital
  More Information

Responsible Party: Paula Kauppi, MD, PhD, MD, PhD, Chief Specialist, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03361072     History of Changes
Other Study ID Numbers: HUS/486/2017
First Submitted: August 11, 2017
First Posted: December 4, 2017
Last Update Posted: December 4, 2017
Last Verified: November 2017

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:
Hypersensitivity
Food Hypersensitivity
Egg Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate