Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food Allergy
|ClinicalTrials.gov 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
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|
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|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|
positive reaction during DBPCFC
no reaction during DBPCFC
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776489
|Contact: Zsolt Szépfalusi, MD||+43 1 40400 ext firstname.lastname@example.org|
|Contact: Susanne C. Diesner, MD, PhD||+43 1 email@example.com|
|Medical University Vienna, Department of Pediatrics and Adolescent Medicine||Recruiting|
|Vienna, Austria, 1090|
|Principal Investigator: Zsolt Szépfalusi, MD|
|Principal Investigator:||Eva Untersmayr-Elsenhuber, MD, PhD||Medical University Vienna, Department of Pathophysiology and Allergy Research|