Clinical trial NCT02666092: Anisakis Blastocystis Cryptosporidium Fish Serology
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy to Fish
Allergy
Anisakis
Keywords: IgE
Immunoelectrophoresis
Western Blot
ImmunoCAP
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Institut Pasteur de Lille
name: ANSES
name: Hôpital Cochin
name: Région Nord-Pas de Calais, France
First posted: 2016-01-28
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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)

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.

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

Primary outcomes:
measure: the frequency of anti-Anisakis and/or anti-fish IgE by serum analysis
timeFrame: contact by phone during 30 min at only visit (inclusion)
Secondary outcomes:
measure: anti-Anisakis and/or anti-fish IgE level by serum analysis
timeFrame: contact by phone during 30 min at only visit (inclusion)
measure: the frequency of anti-Anisakis and anti-fish IgE in patients with fish allergy by serum analysis
timeFrame: contact by phone during 30 min at only visit (inclusion)
measure: nomber of subjects of previous Anisakidae infections
timeFrame: contact by phone during 30 min at only visit (inclusion)
measure: Measure of the performances of serological tests
timeFrame: at work medical visit (inclusion)
measure: The frequency of domestic exposure to fish parasites antigens by questionnaire
timeFrame: contact by phone during 30 min at only visit (inclusion)
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU
Study officials:
affiliation: University Hospital, Lille
name: Emmanuel DUTOIT, MD
role: PRINCIPAL_INVESTIGATOR
References: