NCT05681975

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Oct 2017Dec 2027

Study Start

First participant enrolled

October 1, 2017

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

10 years

First QC Date

January 3, 2023

Last Update Submit

January 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    0 days

Secondary Outcomes (1)

  • Food-specific Immunoglobulin E antibody reactions

    0 days

Interventions

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults presenting symptoms related to adverse reactions to foodstuffs and/ or with suspicion of having a food allergy or food intolerance

You may qualify if:

  • Adults (\>18 years of age)
  • To present symptoms related to adverse reactions to foodstuffs (ARFS)

You may not qualify if:

  • Antibiotic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Politécnica de Madrid

Madrid, 28040, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Capillary whole blood

MeSH Terms

Conditions

Food HypersensitivityImmunoglobulin G4-Related DiseaseSigns and Symptoms

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System DiseasesAutoimmune DiseasesPathological Conditions, Signs and Symptoms

Study Officials

  • Lisset Pantoja-Arévalo, MSc

    Universidad Politecnica de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisset S Pantoja-Arévalo, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Food Engineer, Master of Food Engineering applied to health

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 12, 2023

Study Start

October 1, 2017

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations