- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01776489
Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food Allergy
The Role of Sphingosine-1-phosphate in Food Allergy - Biomarker for Disease Severity and Anaphylaxis Outcome
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).
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Zsolt Szépfalusi, MD
- Phone Number: 3232 +43 1 40400
- Email: zsolt.szepfalusi@meduniwien.ac.at
Study Contact Backup
- Name: Susanne C. Diesner, MD, PhD
- Phone Number: +43 1 40400
- Email: susanne.diesner@meduniwien.ac.at
Study Locations
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Vienna, Austria, 1090
- Recruiting
- Medical University Vienna, Department of Pediatrics and Adolescent Medicine
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Principal Investigator:
- Zsolt Szépfalusi, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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food allergic
positive reaction during DBPCFC
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Non-food allergic
no reaction during DBPCFC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
S1P in allergic and non-allergic patients before and after challenge
Time Frame: up to 3 years
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The primary endpoint of this study is the measurement of S1P in allergic and non-allergic patients before and after challenge.
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up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of allergic mediators and correlation with S1P levels
Time Frame: up to 3 years
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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
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up to 3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eva Untersmayr-Elsenhuber, MD, PhD, Medical University Vienna, Department of Pathophysiology and Allergy Research
Publications and helpful links
General Publications
- 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. Erratum In: Immunol Lett. 2012 Aug 30;146(1-2):79.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 119/2011
- KLI 284-B00 (Other Grant/Funding Number: Austria Science Fund)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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