Anisakis Blastocystis Cryptosporidium Fish Serology

Completed

• Conditions: Allergy; Allergy to Fish; Anisakis
• Interventions: Other: Questionnaire; Biological: Detection of anti-Anisakis and anti-fish antibodies

• Registration Number: NCT02666092
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Detection of anti-Anisakis and anti-fish antibodies	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
Fish allergy	Questionnaire	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
Fish allergy	Detection of anti-Anisakis and anti-fish antibodies	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
Control	Questionnaire	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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)
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.

Trial Locations

Locations (1)

CHRU; 🇫🇷 Lille, France