Food AllergyNCT01776489
Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food Allergy
An observational study of Food Allergy and Anaphylaxis, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Food Allergy, Anaphylaxis
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2011to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Refusal to participate in the study
- Non-IgE-mediated food allergy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna, Department of Pediatrics and Adolescent Medicine
Vienna, 1090
Zsolt Szépfalusi, MD
About this study
Official title: 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).
- Conditions
- Food Allergy, Anaphylaxis
- Keywords
- Food allergy, Sphingosine-1-phosphate, Biomarker, Double-blind placebo-controlled food challenge, Anaphylaxis
- Medical subject headings
- Food Hypersensitivity, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| food allergic | positive reaction during DBPCFC | |
| Non-food allergic | no reaction during DBPCFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 years
Secondary outcomes (1)
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
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startDec 2011
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Untersmayr-Elsenhuber, Medical University of Vienna
- Investigators
- Eva Untersmayr-Elsenhuber, MD, PhD, Principal investigator, Medical University Vienna, Department of Pathophysiology and Allergy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776489
- Sponsor's protocol ID
- 119/2011
- Other IDs
- KLI 284-B00
- Status last verified
- Dec 2015
- First submitted
- 21 Jan 2013
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22020265Olivera 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.
PubMed 20407207Olivera 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.
PubMed 17346996Ammit 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.
PubMed 11344091
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sphingosine-1-phosphate in Food Allergy - Biomarker for Disease Severity and Anaphylaxis Outcome
- ClinicalTrials.gov ID
- NCT01776489
- Acronym / sponsor ID
- 119/2011
- Conditions
- Food Allergy, Anaphylaxis
- Keywords
- Food allergy, Sphingosine-1-phosphate, Biomarker, Double-blind placebo-controlled food challenge, Anaphylaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| food allergic | – | –positive reaction during DBPCFC |
| Non-food allergic | – | –no reaction during DBPCFC |
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal to participate in the study
- Non-IgE-mediated food allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
S1P in allergic and non-allergic patients before and after challenge
Time frame: up to 3 years
The primary endpoint of this study is the measurement of S1P in allergic and non-allergic patients before and after challenge.
1 secondary outcome
Evaluation of allergic mediators and correlation with S1P levels
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Background: PubMed 22020265Diesner 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.
- Background: PubMed 20407207Olivera 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.
- Background: PubMed 17346996Olivera 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.
- Background: PubMed 11344091Ammit 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.
- study centerLink provided by the sponsor.
- study centerLink provided by the sponsor.
- project homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Untersmayr-Elsenhuber, MD, PhD principal investigator
Medical University Vienna, Department of Pathophysiology and Allergy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy and Anaphylaxis, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zsolt Szépfalusi, MD (+43 1 40400 ext. 3232, zsolt.szepfalusi@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S1P in allergic and non-allergic patients before and after challenge (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01776489, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.