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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03361072
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Helsinki University Central Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Paula Kauppi, MD, PhD
Principal Investigator Affiliation Helsinki University Central Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Finland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy
Additional Details

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.

Arms & Interventions

Arms

Experimental: Milk allergy

Milk oral immunotherapy intervention for milk allergy

Experimental: Peanut allergy

Peanut oral immunotherapy intervention for peanut allergy

Experimental: Egg allergy

Egg oral immunotherapy intervention for egg allergy

Interventions

Dietary Supplement: - Oral immunotherapy

Milk, peanut or egg oral immunotherapy

Contact a Trial Team

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International Sites

Helsinki University Central Hospital, Helsinki, Finland

Status

Recruiting

Address

Helsinki University Central Hospital

Helsinki, , 00029

Site Contact

Paula M Kauppi

paula.kauppi@hus.fi

+358504286802

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