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Completed

NCT Number: NCT02666092

Anisakis Blastocystis Cryptosporidium Fish Serology

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).

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Key information

Conditions

Allergy to Fish Allergy Anisakiasis Anisakis Ascaridida Infections Digestive System Diseases Gastrointestinal Diseases Helminthiasis Hypersensitivity Immune System Diseases Infections Intestinal Diseases Intestinal Diseases, Parasitic Nematode Infections Parasitic Diseases Secernentea Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU

Lille, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

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

Biological

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

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

Registry information

Official study 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.

Acronym: ABCFish2

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 28, 2016
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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