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Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food Allergy

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. Read our disclaimer for details. Identifier: NCT01776489
Recruitment Status : Unknown
Verified December 2015 by Eva Untersmayr-Elsenhuber, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : January 28, 2013
Last Update Posted : December 11, 2015
Information provided by (Responsible Party):
Eva Untersmayr-Elsenhuber, Medical University of Vienna

Brief Summary:

Food allergies represent an increasing health concern in the industrialized countries and especially affect pediatric patients. In this population adverse reactions against food compounds can lead to anaphylactic reactions. Despite substantial research efforts, clinical markers predicting disease severity and symptoms are missing to date.

Recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (S1P), play an essential role in allergy. It was reported that asthmatic patients have higher S1P levels in bronchiallavage fluids after allergen challenge. First experimental studies revealed a correlation of S1P and the outcome of anaphylaxis. Furthermore, we have shown in our recent mouse study that S1P homeostasis is pivotal for food allergy induction and effector cell response. Therefore, it is the aim of the presented pilot project to evaluate whether S1P serum titers are altered in food allergic children and if the S1P levels correlate with the outcome of anaphylaxis during double blind placebo controlled food challenges (DBPCFCs).

Condition or disease
Food Allergy Anaphylaxis

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Sphingosine-1-phosphate in Food Allergy - Biomarker for Disease Severity and Anaphylaxis Outcome
Study Start Date : December 2011
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

food allergic
positive reaction during DBPCFC
Non-food allergic
no reaction during DBPCFC

Primary Outcome Measures :
  1. S1P in allergic and non-allergic patients before and after challenge [ Time Frame: up to 3 years ]
    The primary endpoint of this study is the measurement of S1P in allergic and non-allergic patients before and after challenge.

Secondary Outcome Measures :
  1. Evaluation of allergic mediators and correlation with S1P levels [ Time Frame: up to 3 years ]
    Evaluation of allergic mediators like histamine, human mast cell tryptase and eosinophil cationic protein and correlate these results with the levels of S1P within the group and between allergic and non-allergic patients

Biospecimen Retention:   Samples With DNA
whole blood, serum

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children (age 1-17 years) being in medical care at the allergy clinic of the Department of Pediatrics and Adolescent Medicine of the Medical University of Vienna for food related immediate type symptoms (nausea, abdominal pain, vomiting, diarrhea or local symptoms like burning, swelling, itching and erythema) immediately after ingestion of food compounds will be enrolled in this study.

Inclusion Criteria:

  • Patients between 1-17 years who have been reported to suffer from food allergic reactions and who are subjected to DBPCFC or open provocation
  • Patients who are diagnosed by elevated allergen specific IgE and/or positive skin prick testing
  • Willingness to participate in the study

Exclusion Criteria:

  • Refusal to participate in the study
  • Non-IgE-mediated food allergy

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 identifier (NCT number): NCT01776489

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Contact: Zsolt Szépfalusi, MD +43 1 40400 ext 3232
Contact: Susanne C. Diesner, MD, PhD +43 1 40400

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Medical University Vienna, Department of Pediatrics and Adolescent Medicine Recruiting
Vienna, Austria, 1090
Principal Investigator: Zsolt Szépfalusi, MD         
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Eva Untersmayr-Elsenhuber, MD, PhD Medical University Vienna, Department of Pathophysiology and Allergy Research

Additional Information:
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Responsible Party: Eva Untersmayr-Elsenhuber, Assoc. Prof., Dr., Medical University of Vienna Identifier: NCT01776489    
Other Study ID Numbers: 119/2011
KLI 284-B00 ( Other Grant/Funding Number: Austria Science Fund )
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by Eva Untersmayr-Elsenhuber, Medical University of Vienna:
Food allergy
Double-blind placebo-controlled food challenge
Additional relevant MeSH terms:
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Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate