FARE - Food Allergy Research & Education Logo

Feasibility Study of a New Immunoglobulin E (IgE) Assay Method

Study Purpose

The main objective is to study the feasibility of a new specific IgE assay using a bioluminescence technique in a pediatric and adult allergic population. For this, we will collect blood, and urine during a blood test scheduled for the follow-up of the patient.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 6 Months - 99 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Males or females 6 months' old or older.
  • - Sensitization or allergy towards a trophallergen, an aeroallergen, hymenoptera venom or drug proven by: - positive skin test (s) - and / or IgE specific (s)> 0.1 kUA / L.
  • - and / or anamnesis in favor of an allergic reaction of mediated IgE.
  • - Social coverage up to date.

Exclusion Criteria:

  • - Children younger than 6 months'old.
  • - Children's weight less than 10 kg.
  • - Pregnant or breastfeeding women.
  • - Patients with cystic fibrosis.
  • - Patients with dysimmune or autoimmune pathology.
  • - Anamnesis in favor of a delayed allergy or a contact allergy.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Toulouse
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marine Michelet, MD
Principal Investigator Affiliation University Hospital, Toulouse
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries France

The disease, disorder, syndrome, illness, or injury that is being studied.

Allergy and Immunology
Additional Details

Allergy is a raising public health problem. Specific IgE assays are useful tools to investigate the physiopathology of allergies. This method is achieved mainly by the ImmunoCAP enzyme immunoassay technique. This is an expensive test that requires a significant amount of blood. This is a limitation particularly in children. The time to get the results is long and a second consultation has to be scheduled in order to communicate the results to the patients. The main objective of this study is to assess the feasibility of a new specific IgE assay, named LuLISA, using a bioluminescence technique in urine and blood samples from pediatric and adult allergic population. This technique was recently published for the quantification of IgE against two peanut allergens and needs to be extended for the detection of other major allergens. A secondary objective is the evaluation of the time needed to obtain results.

Arms & Interventions


: People with sensitization or allergy

blood and urine will be collected during a blood test scheduled for the follow-up of the patient


Biological: - collection of blood and urine

blood and urine will be collected during a blood test scheduled for the follow-up of the patient

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University Hospital, Toulouse, France




University Hospital

Toulouse, , 31000

Site Contact

Marine Michelet, MD


5 34 55 85 86 #0033

Larrey hospital, Toulouse, France




Larrey hospital

Toulouse, , 31059

Site Contact

Laurent Guilleminault, MD


567771624 #0033

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.