ABCFish2: Anisakis Blastocystis Cryptosporidium Fish Serology

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT02666092

Collaborator

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

105

Enrollment

Location

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Allergy to Fish Allergy Anisakis	Other: Questionnaire Biological: Detection of anti-Anisakis and anti-fish antibodies

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 Design

Study Type:

Observational

Actual Enrollment :

105 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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.

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

the frequency of anti-Anisakis and/or anti-fish IgE by serum analysis [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.

Secondary Outcome Measures

anti-Anisakis and/or anti-fish IgE level by serum analysis [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.
the frequency of anti-Anisakis and anti-fish IgE in patients with fish allergy by serum analysis [contact by phone during 30 min at only visit (inclusion)]
nomber of subjects of previous Anisakidae infections [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.
Measure of the performances of serological tests [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.
The frequency of domestic exposure to fish parasites antigens by questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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