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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Eva Untersmayr-Elsenhuber, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01776489
First received: January 21, 2013
Last updated: January 23, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776489

Contacts
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

Locations
Austria
Medical University Vienna, Department of Pediatrics and Adolescent Medicine Recruiting
Vienna, Austria, 1090
Principal Investigator: Zsolt Szépfalusi, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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 July 29, 2014