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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: The Role of Sphingosine-1-phosphate in Food Allergy - Biomarker for Disease Severity and Anaphylaxis Outcome

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).


Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: January 21, 2013
Date Started: December 2011
Date Completion: January 2017
Last Updated: December 9, 2015
Last Verified: December 2015