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

NCT01776489 | Unknown

• 2 other identifiers: 119/2011KLI 284-B00
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Food Allergy; Anaphylaxis

Keywords

Food allergy; Sphingosine-1-phosphate; Biomarker; Double-blind placebo-controlled food challenge; Anaphylaxis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Evaluation of allergic mediators and correlation with S1P levels

  up to 3 years

Study Arms (2)

food allergic

positive reaction during DBPCFC

Non-food allergic

no reaction during DBPCFC

Eligibility Criteria

• Age: 12 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Refusal to participate in the study
• Non-IgE-mediated food allergy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna, Department of Pediatrics and Adolescent Medicine

Vienna, 1090, Austria

RECRUITING

Related Publications (4)

• 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.

  PMID: 22020265 BACKGROUND

• 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.

  PMID: 20407207 BACKGROUND

• 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.

  PMID: 17346996 BACKGROUND

• 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.

  PMID: 11344091 BACKGROUND

Related Links

• study center
• study center
• project homepage

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Food Hypersensitivity; Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Eva Untersmayr-Elsenhuber, MD, PhD

  Medical University Vienna, Department of Pathophysiology and Allergy Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zsolt Szépfalusi, MD

CONTACT

+43 1 40400; zsolt.szepfalusi@meduniwien.ac.at

Susanne C. Diesner, MD, PhD

CONTACT

+43 1 40400; susanne.diesner@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof., Dr.

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 28, 2013
• Study Start: December 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

AU (1)