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

Food Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01776489
• Other study ID #: 119/2011
• Secondary ID: KLI 284-B00
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2013
• Last updated: December 9, 2015
• Start date: December 2011
• Est. completion date: January 2017

Study information

• Verified date: December 2015
• Source: Medical University of Vienna
• Contact: Zsolt Szépfalusi, MD
• Phone: +43 1 40400
• Email: zsolt.szepfalusi[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethics committee of the Medical University Vienna
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 17 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anaphylaxis
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Locations

Country	Name	City	State
Austria	Medical University Vienna, Department of Pediatrics and Adolescent Medicine	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (4)

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. — View Citation

Diesner SC, Olivera A, Dillahunt S, Schultz C, Watzlawek T, Förster-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. Erratum in: Immunol Lett. 2012 Aug 30;146(1-2):79. — View 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. — View 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. Epub 2007 Mar 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S1P in allergic and non-allergic patients before and after challenge	The primary endpoint of this study is the measurement of S1P in allergic and non-allergic patients before and after challenge.	up to 3 years	Yes
Secondary	Evaluation of allergic mediators and correlation with S1P levels	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	up to 3 years	Yes

External Links

•   project homepage
•   study center
•   study center