Clinical trial NCT01776489: Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food Allergy
Official title: The Role of Sphingosine-1-phosphate in Food Allergy - Biomarker for Disease Severity and Anaphylaxis Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Food Allergy
Anaphylaxis
Keywords: Food allergy
Sphingosine-1-phosphate
Biomarker
Double-blind placebo-controlled food challenge
Anaphylaxis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: S1P in allergic and non-allergic patients before and after challenge
timeFrame: up to 3 years
Secondary outcomes:
measure: Evaluation of allergic mediators and correlation with S1P levels
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Pediatrics and Adolescent Medicine
Study officials:
affiliation: Medical University Vienna, Department of Pathophysiology and Allergy Research
name: Eva Untersmayr-Elsenhuber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diesner SC, Olivera A, Dillahunt S, Schultz C, Watzlawek T, Forster-Waldl E, Pollak A, Jensen-Jarolim E, Untersmayr E, Rivera J. Sphingosine-kinase 1 and 2 contribute to oral sensitization and effector phase in a mouse model of food allergy. Immunol Lett. 2012 Jan 30;141(2):210-9. doi: 10.1016/j.imlet.2011.10.006. Epub 2011 Oct 14.
citation: Olivera A, Eisner C, Kitamura Y, Dillahunt S, Allende L, Tuymetova G, Watford W, Meylan F, Diesner SC, Li L, Schnermann J, Proia RL, Rivera J. Sphingosine kinase 1 and sphingosine-1-phosphate receptor 2 are vital to recovery from anaphylactic shock in mice. J Clin Invest. 2010 May;120(5):1429-40. doi: 10.1172/JCI40659. Epub 2010 Apr 19.
citation: Olivera A, Mizugishi K, Tikhonova A, Ciaccia L, Odom S, Proia RL, Rivera J. The sphingosine kinase-sphingosine-1-phosphate axis is a determinant of mast cell function and anaphylaxis. Immunity. 2007 Mar;26(3):287-97. doi: 10.1016/j.immuni.2007.02.008. Epub 2007 Mar 8.
citation: Ammit AJ, Hastie AT, Edsall LC, Hoffman RK, Amrani Y, Krymskaya VP, Kane SA, Peters SP, Penn RB, Spiegel S, Panettieri RA Jr. Sphingosine 1-phosphate modulates human airway smooth muscle cell functions that promote inflammation and airway remodeling in asthma. FASEB J. 2001 May;15(7):1212-4. doi: 10.1096/fj.00-0742fje. No abstract available.