The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Helsinki University Central Hospital
Sponsor:
Information provided by (Responsible Party):
Paula Kauppi, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01822353
First received: March 7, 2013
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old children is 9%, and the most common allergen is milk. The overall food allergy has been reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood. In addition, it predicts later development of allergic disease such as asthma. Most of the egg and milk allergy is transient and disappears in childhood. Currently, the standard of care for food allergy includes strict allergen avoidance. However, oral immunotherapy has been under investigation in children milk, egg, and wheat allergy. Previously, induction of clinical egg tolerance has been reported with egg oral immunotherapy in children aged from 3 to 13 years. In adults, strict avoidance is still the standard care but there is also growing interest in treatment of severe food allergy with oral immunotherapy or anti-IgE.

The investigators aim to analyse the results of per oral immunotherapy treatment in severe IgE-mediated egg, milk, and nut allergy in adults.

Could severe egg, milk and nut allergy be treated with oral immunotherapy treatment in stead of total allergen avoidance and could desensitization thus be achieved?


Condition Intervention Phase
Food Allergy
Dietary Supplement: Dietary supplement
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk and Nut Allergy in Adults

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Number of the patients that achieve higher tolerance of allergen with immunotherapy than the measured baseline allergen challenge shows? [ Time Frame: One year ] [ Designated as safety issue: No ]
    Number of the patients that achieve higher tolerance of allergen with immunotherapy than the measured baseline allergen challenge shows.


Secondary Outcome Measures:
  • Effect of therapy on lung function. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Does hyposensitisation change lung function (do spirometry tests show difference from the baseline values (= before immunotherapy) after the immunotherapy) ?

  • Does oral immunotherapy change bronchial hyperreactivity? [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Does bronchial hyperreactivity (measured with methacholine bronchial challenge test) show change from the baseline level after the immunotherapy?

  • Does the oral immunotherapy have en effect on airway inflammation? [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Does the oral immunotherapy change exhaled nitric oxide levels (measured before and after immunotherapy)


Other Outcome Measures:
  • Safety of oral immunotherapy in severe IgE mediated food allergy in adults. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    How many of the patients have side effects (categorized as mild, moderate or severe)of the hyposensitisation and how many of the patients discontinue the therapy because of side effects?

  • Effect of treatment on quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
    Quality of life is assessed by a questionnaire before and after immunotherapy.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milk allergy
Dietary supplement, milk in increasing dosages, delivered daily and orally.
Dietary Supplement: Dietary supplement
Milk, egg or nut oral immunotherapy
Other Names:
  • Milk
  • Egg protein
  • Nut cream
Experimental: Egg allergy
Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Dietary Supplement: Dietary supplement
Milk, egg or nut oral immunotherapy
Other Names:
  • Milk
  • Egg protein
  • Nut cream
Experimental: Nut allergy
Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Dietary Supplement: Dietary supplement
Milk, egg or nut oral immunotherapy
Other Names:
  • Milk
  • Egg protein
  • Nut cream

Detailed Description:

Up to 100 subjects are studied. All subjects are adults having no other severe chronic diseases. The subjects belong to four different groups:

  1. 30 18-50 year olds who start per oral immunotherapy treatment in severe egg allergy.
  2. 30 18-50 year olds who start per oral immunotherapy treatment in severe milk allergy.
  3. 30 18-50 year olds who start per oral immunotherapy treatment in severe nut allergy.
  4. 10 milk allergic 18-50 year olds that have been treated as pilot patients with milk hyposensitisation treatment.

The diagnosis of milk or egg allergy is verified with positive history, skin prick test, egg, milk and nut allergen specific IgE antibodies. In addition, food allergy is verified with an allergen specific challenge test.

Atopic subjects may have simultaneously other allergies. Intermittent mild asthma, and mild and moderate persistent asthma are tolerated and treatment with inhaled steroids and other asthma medication is allowed. Atopic subjects may have additional skin symptoms. Quality of life, anxiety and patient history data is collected by questionnaires. All patients undergo a spirometry with a bronchodilatation test, fractional exhaled nitric oxide and a methacholine challenge before and a year after oral immunotherapy. Those with test results diagnostic for asthma are treated with asthma medication before hyposensitisation treatment is started.

Exclusion criteria: adults with instable cerebrovascular or heart disease, active autoimmune disease or cancer, or use of betablocker agents. In addition, poorly controlled asthma or FEV1 < 70% are not tolerated.

In oral immunotherapy, increasing doses are given first observed, and then daily at home. If the subject does not tolerate a given dose and symptoms are mild, then that dose or the previously tolerated one is repeated, and the protocol proceeds as outlined. If the subject experiences significant symptoms, then the protocol is stopped, and the highest tolerated dose is used as the starting daily one.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • severe IgE-mediated milk allergy or
  • severe IgE-mediated egg allergy or
  • severe IgE-mediated nut allergy or
  • 18-50 years

Exclusion Criteria:

  • instable cerebrovascular or heart disease
  • active autoimmune disease or cancer
  • use of betablocker agents
  • poorly controlled asthma
  • FEV1 < 70% of the predicted
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822353

Contacts
Contact: Paula M Kauppi, MD, PhD +35894711 paula.kauppi@hus.fi
Contact: Mika J Mäkelä, MD, PhD mika.makela@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
Study Director: Mika J Mäkelä, MD, PhD Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Paula Kauppi, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01822353     History of Changes
Other Study ID Numbers: HUS21813030112
Study First Received: March 7, 2013
Last Updated: April 1, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University Central Hospital:
food allergy
milk allergy
egg allergy
nut allergy

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

ClinicalTrials.gov processed this record on August 28, 2014