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Cow's Milk and Hen's Egg Hyposensitization in Adults

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ClinicalTrials.gov Identifier: NCT02083471
Recruitment Status : Unknown
Verified October 2015 by Turku University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 11, 2014
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital

Brief Summary:
Egg, milk and cereal allergies are the most important food allergies in Finnish children, the prevalence in western countries is 1-4 %. In some individuals food-allergy is maintained in to adulthood. Recent studies suggest that specific oral tolerance induction (SOTI) provides a treatment option in children with continuing allergy with high success rates. The study aims at specific oral tolerance induction in adults allergic to cow's milk or hen's egg. Oral immunotherapy involves taking very small amounts of the allergen, and slowly increasing the amount. Consequently, an elimination diet may be wholly or partially cancelled, without the fear of serious allergic reactions. Another aim is to explore changes in antibody-mediated and cell-mediated immune response to individual components of cow's milk and egg allergens during tolerance induction and compare these with the effect of the treatment.

Condition or disease Intervention/treatment Phase
Egg Allergy Cow's Milk Allergy Dietary Supplement: Specific Oral Tolerance Induction with Egg or Cow's milk Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cow's Milk and Hen's Egg Hyposensitization in Adults
Study Start Date : April 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: SOTI
Specific Oral Tolerance Induction with Egg or Cow's milk
Dietary Supplement: Specific Oral Tolerance Induction with Egg or Cow's milk
No Intervention: Food Allergy follow-up



Primary Outcome Measures :
  1. Number of subjects with negative results [ Time Frame: 12 months after commencement ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allergy to Egg or Cow's milk verified by challenge history and specific IgE

Exclusion Criteria:

  • Cardiovascular disease
  • Active immunological disease

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): NCT02083471


Contacts
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Contact: Johannes Savolainen, MD Professor 407172029 ext +358 johannes.savolainen@tyks.fi

Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Johannes Savolainen, MD Professor University of Turku

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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02083471     History of Changes
Other Study ID Numbers: UTU-ClinAll-0112
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Hypersensitivity
Milk Hypersensitivity
Egg Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate