Immunoglobulin E-Mediated Food AllergyNCT05681975
Immunoglobulin G4 and Immunoglobulin E Antibodies in a Population With Adverse Reactions to Foodstuffs-related Symptoms
An observational study of Immunoglobulin E-Mediated Food Allergy and Immunoglobulin G4-Related Disease, run by Universidad Politecnica de Madrid at 1 site in Spain.
Trial summary
The aim of this study is to analyze a population with symptoms associated with adverse reactions to foodstuffs (ARFS). To determine the levels of food-specific immunoglobulin G4 (IgG4) and immunoglobulin E (IgE) antibody reactions (AbR). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunoglobulin E-Mediated Food Allergy, Immunoglobulin G4-Related Disease, Symptoms and Signs
- What is being tested?
- Food-specific Immunoglobulin G4 and/or Immunoglobulin E antibody reactions
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2017to Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults presenting symptoms related to adverse reactions to foodstuffs and/ or with suspicion of having a food allergy or food intolerance
Who may be able to join
- Adults (>18 years of age)
- To present symptoms related to adverse reactions to foodstuffs (ARFS)
Who cannot join
- Antibiotic treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad Politécnica de Madrid
Madrid, 28040
Lisset Pantoja-Arévalo, MSc, +34 910677879 ext. 77879, l.pantoja@upm.es
About this study
Official title: Food-specific Immunoglobulin G4 and Immunoglobulin E Antibody Reactions in a Population With Adverse Reactions to Foodstuffs-related Symptoms
The aim of this study is to analyze a population with symptoms associated with adverse reactions to foodstuffs (ARFS). To determine the levels of food-specific immunoglobulin G4 (IgG4) and immunoglobulin E (IgE) antibody reactions (AbR).
Read the detailed description
Volunteers with symptoms related with adverse reactions to foodstuffs (ARFS) and suspicion of having a food allergy or a food intolerance are enrolled in this study. A 50μl of capillary whole blood is analyzed and the levels of food-specific immunoglobulin G4 (IgG4) or immunoglobulin E (IgE) antibody reactions (AbR) are determined.
- Conditions
- Immunoglobulin E-Mediated Food Allergy, Immunoglobulin G4-Related Disease, Symptoms and Signs, Adverse Reaction to Food
- Being tested
- Food-specific Immunoglobulin G4 and/or Immunoglobulin E antibody reactions
- Medical subject headings
- Food Hypersensitivity, Immunoglobulin G4-Related Disease, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food-specific Immunoglobulin G4 and/or Immunoglobulin E antibody reactionsDiagnostic test
Immunoassay kits (NutriSMART® and Fastcheckpoc20® In-Vitro Diagnostic kits, DST GmbH, Schwerin, Germany) are performed in a population with suspicion of having a food allergy or a food intolerance with related symptoms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Food-specific Immunoglobulin G4 antibody reactions
Immunoassay kits (NutriSMART® In-Vitro Diagnostic kit, DST GmbH, Schwerin, Germany) are performed in a population with suspicion of having a food allergy or a food intolerance with related symptoms.
Measured: 0 days
Secondary outcomes (1)
Food-specific Immunoglobulin E antibody reactions
Immunoassay kits (Fastcheckpoc20® In-Vitro Diagnostic kit, DST GmbH, Schwerin, Germany) are performed in a population with suspicion of having a food allergy or a food intolerance with related symptoms.
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Oct 2017
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin E-Mediated Food AllergyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisset Pantoja Arevalo, Universidad Politecnica de Madrid
- Investigators
- Lisset Pantoja-Arévalo, MSc, Principal investigator, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681975
- Sponsor's protocol ID
- 1720IL0389
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food-specific Immunoglobulin G4 and Immunoglobulin E Antibody Reactions in a Population With Adverse Reactions to Foodstuffs-related Symptoms
- ClinicalTrials.gov ID
- NCT05681975
- Acronym / sponsor ID
- 1720IL0389
- Conditions
- Immunoglobulin E-Mediated Food Allergy, Immunoglobulin G4-Related Disease, Symptoms and Signs, Adverse Reaction to Food
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Jan 2023 (actual)
- 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.
The aim of this study is to analyze a population with symptoms associated with adverse reactions to foodstuffs (ARFS). To determine the levels of food-specific immunoglobulin G4 (IgG4) and immunoglobulin E (IgE) antibody reactions (AbR).
Detailed description
Volunteers with symptoms related with adverse reactions to foodstuffs (ARFS) and suspicion of having a food allergy or a food intolerance are enrolled in this study. A 50μl of capillary whole blood is analyzed and the levels of food-specific immunoglobulin G4 (IgG4) or immunoglobulin E (IgE) antibody reactions (AbR) are determined.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults presenting symptoms related to adverse reactions to foodstuffs and/ or with suspicion of having a food allergy or food intolerance
Key inclusion criteria (2 listed)
- Adults (>18 years of age)
- To present symptoms related to adverse reactions to foodstuffs (ARFS)
Key exclusion criteria (1 listed)
- Antibiotic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food-specific Immunoglobulin G4 and/or Immunoglobulin E antibody reactionsImmunoassay kits (NutriSMART® and Fastcheckpoc20® In-Vitro Diagnostic kits, DST GmbH, Schwerin, Germany) are performed in a population with suspicion of having a food allergy or a food intolerance with related symptoms. | Diagnostic test | – |
Primary outcome
Food-specific Immunoglobulin G4 antibody reactions
Time frame: 0 days
Immunoassay kits (NutriSMART® In-Vitro Diagnostic kit, DST GmbH, Schwerin, Germany) are performed in a population with suspicion of having a food allergy or a food intolerance with related symptoms.
1 secondary outcome
Food-specific Immunoglobulin E antibody reactions
Time frame: 0 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
Lisset Pantoja-Arévalo, MSc principal investigator
Universidad Politecnica de Madrid
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 Immunoglobulin E-Mediated Food Allergy and Immunoglobulin G4-Related Disease, run by Universidad Politecnica de Madrid at 1 site in Spain.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Jan 2023. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisset S Pantoja-Arévalo, MSc (+34910677879 ext. 77879, l.pantoja@upm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food-specific Immunoglobulin G4 antibody reactions (time frame: 0 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2023.