Anisakis Blastocystis Cryptosporidium Fish Serology (ABCFish2)

January 17, 2017 updated by: University Hospital, Lille

Protists and Nematodes Fish Parasites: From Their Circulation in Ecosystems to Their Impact on Human Health - Role of Anisakidae and/or Fish Flesh Antigens in Fish Allergies.

Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them are recognized as zoonotic diseases agents, and have a high impact on human health.

Infestation results from the ingestion of living larvae from contaminated fishes. It can be asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms. Allergic manifestations are frequently encountered in gastric forms, but allergic symptoms can also occur in isolation, after ingestion of Anisakidae antigens contained in raw or cooked fish, and may masquerade as fish allergy.

In this study, we aim to characterize the relationship between Anisakidae and/or fish sensitization and the presence of allergic manifestations in patients recruited in the general population and presenting fish allergy resulting from ingestion, cutaneous or respiratory contact. We will also determine the respective role of Anisakidae or fish sensitization in patients with fish allergy. Then, we will determine the prevalence of previous Anisakidae infections among these patients and a matched control population. We will also compare the performances of serological tests (ImmunoCAP, immunoelectrophoresis and Western Blot) for the diagnosis of Anisakidae allergy or infection. Lastly, we will explore the relationship between domestic exposure to Anisakidae or fish antigens and the occurrence of associated pathologies (Anisakidae or fish allergy/sensitization; Anisakidae infection).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

First, 51 patients with fish allergy will be recruited from the Parasitology-Mycology and Immunology Laboratories of Lille University Hospital databases (serology for anti-Anisakis or anti-fish detection). Then, clinical (characteristics of allergic manifestations) and epidemiological (domestic exposure to fish) data will be collected, and anti-fish or Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), or ImmunoCAP, immunoelectrophoresis, Western Blot, respectively. Similar serological tests will be performed for a control group of 51 matched subjects who will be recruited among Lille University Hospital workers.

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The recruited population will include:

  • 51 patients with fish allergy
  • 51 matched control subjects (sex, age +/- 5 years)

Description

Inclusion Criteria:

ALLERGIC PATIENTS:

  • Previous serological assessment for anti-Anisakis or anti-fish antibodies detection (ImmunoCap and/or immunoelectrophoresis) in Lille University Hospital Center, and volume of serum conserved ≥500 µl
  • Allergic manifestations after contact with fish (asthma, allergic rhinitis, conjunctivitis, chronic or acute urticaria, dermatitis/eczema, eosinophilic gastroenteritis, gingivostomatitis, angioedema, bronchospasm, anaphylaxis)

CONTROL SUBJECTS:

  • Serological assessment for infectious disease during a routine occupational health consultation in Lille University Hospital Center
  • Absence of fish allergy

Exclusion Criteria:

  • Pregnant or breast-feeding female
  • Patient with no social insurance
  • Patient unwilling to comply with the protocol
  • Patient unable to understand the study and its objectives
  • Patient under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fish allergy

51 subjects presenting allergic manifestations after digestive, cutaneous, or respiratory contact with fish will be recruited.

Interventions will include:

  • A questionnaire on domestic exposure to fish, and on the characteristics of clinical manifestations
  • A detection of anti-Anisakis and anti-fish antibodies
Other: Questionnaire
Questionnaire on domestic exposure to fish, and, for patients with fish allergy, on the characteristics of clinical manifestations)
Biological: Detection of anti-Anisakis and anti-fish antibodies
Anti-fish IgE will be detected using ImmunoCAP. Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), immunoelectrophoresis (precipitins) and Western Blot.
Control

51 subjects presenting no allergic manifestations after contact with fish.

Interventions will include:

  • A questionnaire on domestic exposure to fish
  • A detection of anti-Anisakis and anti-fish antibodies
Other: Questionnaire
Questionnaire on domestic exposure to fish, and, for patients with fish allergy, on the characteristics of clinical manifestations)
Biological: Detection of anti-Anisakis and anti-fish antibodies
Anti-fish IgE will be detected using ImmunoCAP. Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), immunoelectrophoresis (precipitins) and Western Blot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the frequency of anti-Anisakis and/or anti-fish IgE by serum analysis
Time Frame: contact by phone during 30 min at only visit (inclusion)
comparison between subjects with fish allergy and a matched control population, presenting no fish allergy.
contact by phone during 30 min at only visit (inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anti-Anisakis and/or anti-fish IgE level by serum analysis
Time Frame: contact by phone during 30 min at only visit (inclusion)
Comparison between subjects with fish allergy and a matched control population, presenting no fish allergy.
contact by phone during 30 min at only visit (inclusion)
the frequency of anti-Anisakis and anti-fish IgE in patients with fish allergy by serum analysis
Time Frame: contact by phone during 30 min at only visit (inclusion)
contact by phone during 30 min at only visit (inclusion)
nomber of subjects of previous Anisakidae infections
Time Frame: contact by phone during 30 min at only visit (inclusion)
questionnaire-based diagnosis, supported by serological testing between patients with fish allergy and a matched control population, presenting no fish allergy.
contact by phone during 30 min at only visit (inclusion)
Measure of the performances of serological tests
Time Frame: at work medical visit (inclusion)
Comparison of the performances of serological tests (ImmunoCAP, immunoelectrophoresis and Western Blot) for the diagnosis of Anisakidae allergy or infection.
at work medical visit (inclusion)
The frequency of domestic exposure to fish parasites antigens by questionnaire
Time Frame: contact by phone during 30 min at only visit (inclusion)

It will be compared between Anisakis or fish allergic/sensitized subjects and non-allergic/non sensitized subjects.

It will be compared between patients with or without previous Anisakidosis. Fish exposure will be determined taking into account the handled fish species and the local prevalences of fish parasites.
contact by phone during 30 min at only visit (inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Hôpital Cochin
Institut Pasteur de Lille
Région Nord-Pas de Calais, France
ANSES

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (ESTIMATE)

January 28, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013_43
  • 2014-A00855-42 (OTHER: ID RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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