Anisakis Blastocystis Cryptosporidium Fish Serology

NCT ID: NCT02666092

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-01-31

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).

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.

Conditions

Allergy to Fish; Allergy; Anisakis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Questionnaire

Intervention Type: OTHER

Questionnaire on domestic exposure to fish, and, for patients with fish allergy, on the characteristics of clinical manifestations)

Detection of anti-Anisakis and anti-fish antibodies

Intervention Type: BIOLOGICAL

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

Questionnaire

Intervention Type: OTHER

Questionnaire on domestic exposure to fish, and, for patients with fish allergy, on the characteristics of clinical manifestations)

Detection of anti-Anisakis and anti-fish antibodies

Intervention Type: BIOLOGICAL

Anti-fish IgE will be detected using ImmunoCAP. Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), immunoelectrophoresis (precipitins) and Western Blot.

Interventions

Questionnaire

Questionnaire on domestic exposure to fish, and, for patients with fish allergy, on the characteristics of clinical manifestations)

Intervention Type: OTHER

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Pasteur de Lille

OTHER

Sponsor Role: collaborator

ANSES

OTHER

Sponsor Role: collaborator

Hôpital Cochin

OTHER

Sponsor Role: collaborator

Région Nord-Pas de Calais, France

OTHER

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel DUTOIT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

CHRU

Lille, , France

Countries

France

Other Identifiers

2014-A00855-42

Identifier Type: OTHER

Identifier Source: secondary_id

2013_43

Identifier Type: -

Identifier Source: org_study_id