Anisakis Blastocystis Cryptosporidium Fish Serology

Allergy Clinical Trial

— ABCFish2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666092
• Other study ID #: 2013_43
• Secondary ID: 2014-A00855-42
• Status: Completed
• Phase: N/A
• First received: January 25, 2016
• Last updated: January 17, 2017
• Start date: February 2015
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergy
• Allergy to Fish
• Anisakis
• Hypersensitivity

Intervention

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.

Locations

Country	Name	City	State
France	CHRU	Lille

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Lille	ANSES, Boulogne-sur-Mer, Hôpital Cochin, Institut Pasteur de Lille, Région Nord-Pas de Calais, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the frequency of anti-Anisakis and/or anti-fish IgE by serum analysis	comparison between subjects with fish allergy and a matched control population, presenting no fish allergy.	contact by phone during 30 min at only visit (inclusion)
Secondary	anti-Anisakis and/or anti-fish IgE level by serum analysis	Comparison between subjects with fish allergy and a matched control population, presenting no fish allergy.	contact by phone during 30 min at only visit (inclusion)
Secondary	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)
Secondary	nomber of subjects of previous Anisakidae infections	questionnaire-based diagnosis, supported by serological testing between patients with fish allergy and a matched control population, presenting no fish allergy.	contact by phone during 30 min at only visit (inclusion)
Secondary	Measure of the performances of serological tests	Comparison of the performances of serological tests (ImmunoCAP, immunoelectrophoresis and Western Blot) for the diagnosis of Anisakidae allergy or infection.	at work medical visit (inclusion)
Secondary	The frequency of domestic exposure to fish parasites antigens by questionnaire	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.	contact by phone during 30 min at only visit (inclusion)