Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food Allergy
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Purpose
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).
| Condition |
|---|
|
Food Allergy Anaphylaxis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Role of Sphingosine-1-phosphate in Food Allergy - Biomarker for Disease Severity and Anaphylaxis Outcome |
- S1P in allergic and non-allergic patients before and after challenge [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]The primary endpoint of this study is the measurement of S1P in allergic and non-allergic patients before and after challenge.
- Evaluation of allergic mediators and correlation with S1P levels [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]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
Biospecimen Retention: Samples With DNA
whole blood, serum
| Estimated Enrollment: | 70 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
food allergic
positive reaction during DBPCFC
|
|
Non-food allergic
no reaction during DBPCFC
|
Eligibility| Ages Eligible for Study: | 12 Months to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| Contact: Zsolt Szépfalusi, MD | +43 1 40400 ext 3232 | zsolt.szepfalusi@meduniwien.ac.at |
| Contact: Susanne C. Diesner, MD, PhD | +43 1 40400 | susanne.diesner@meduniwien.ac.at |
| Austria | |
| Medical University Vienna, Department of Pediatrics and Adolescent Medicine | Recruiting |
| Vienna, Austria, 1090 | |
| Principal Investigator: Zsolt Szépfalusi, MD | |
| Principal Investigator: | Eva Untersmayr-Elsenhuber, MD, PhD | Medical University Vienna, Department of Pathophysiology and Allergy Research |
More Information
Additional Information:
Publications:
| Responsible Party: | Eva Untersmayr-Elsenhuber, Assoc. Prof., Dr., Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01776489 History of Changes |
| Other Study ID Numbers: | 119/2011, KLI 284-B00 |
| Study First Received: | January 21, 2013 |
| Last Updated: | January 23, 2013 |
| Health Authority: | Austria: Ethics committee of the Medical University Vienna |
Keywords provided by Medical University of Vienna:
|
Food allergy Sphingosine-1-phosphate Biomarker Double-blind placebo-controlled food challenge Anaphylaxis |
Additional relevant MeSH terms:
|
Hypersensitivity Anaphylaxis Food Hypersensitivity Immune System Diseases Hypersensitivity, Immediate |
ClinicalTrials.gov processed this record on June 18, 2013