Overview

This trial has been completed.

Conditions anisakis, allergy, occupational exposure
Treatment questionnaire
Sponsor University Hospital, Lille
Collaborator Institut Pasteur de Lille
Start date November 2014
End date October 2016
Trial size 486 participants
Trial identifier NCT02661074, 2013_42, 2014-A00853-44

Summary

Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them are recognized as zoonotic 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 isolated allergic symptoms can occur after ingestion of Anisakidae antigens in raw or cooked fish. Cutaneous contact or Anisakis allergen inhalation have also been reported to induce allergy/anaphylactic reactions or sensitization in the occupational setting in Spain, Italy, Sicilia or South Africa. But no data is available in France.

In this context, the investigators propose to determine and compare the frequency and characteristics of fish allergy in fish workers (fishermen and fish-processing factory workers) and a control population of workers without occupational exposure to fish, in Boulogne-sur-Mer, which is an important fishing port in France, and the first European center for fish processing.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Fisherman followed by the "Service de Santé des Gens de Mer" of Boulogne-sur-Mer, France (occupational exposure to fish). A questionnaire will be completed.
questionnaire
A questionnaire will be completed in order to collect data on: Potential allergic manifestations after fish contact: asthma, allergic rhinitis, conjunctivitis, chronic or acute urticaria, dermatitis/eczema, or severe allergic manifestations (angioedema, bronchospasm, anaphylaxis), Occupational and/or domestic exposure to fish.
Workers of fish processing factories who are followed by the "Service de Santé au Travail" (ASTIL) of Boulogne-sur-Mer, France (occupational exposure to fish). A questionnaire will be completed.
questionnaire
A questionnaire will be completed in order to collect data on: Potential allergic manifestations after fish contact: asthma, allergic rhinitis, conjunctivitis, chronic or acute urticaria, dermatitis/eczema, or severe allergic manifestations (angioedema, bronchospasm, anaphylaxis), Occupational and/or domestic exposure to fish.
Workers who are followed by the "Service de Santé au Travail" (ASTIL) of Boulogne-sur-Mer, France, but do not work in fish processing factories. A questionnaire will be completed.
questionnaire
A questionnaire will be completed in order to collect data on: Potential allergic manifestations after fish contact: asthma, allergic rhinitis, conjunctivitis, chronic or acute urticaria, dermatitis/eczema, or severe allergic manifestations (angioedema, bronchospasm, anaphylaxis), Occupational and/or domestic exposure to fish.

Primary Outcomes

Measure
The prevalence of fish allergy
time frame: contact by phone during 30 min at only visit (inclusion)

Secondary Outcomes

Measure
Frequencies history of infections Anisakis spp.
time frame: contact by phone during 30 min at only visit (inclusion)
Frequency of fish allergies, history of infections Anisakis spp. (clinical diagnosis)
time frame: contact by phone during 30 min at only visit (inclusion)
history of infections Anisakis spp. (clinical diagnosis)
time frame: contact by phone during 30 min at only visit (inclusion)
Frequency of risk factors for occupational or domestic exposure to fish:
time frame: contact by phone during 30 min at only visit (inclusion)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Fisherman followed by the "Service de Santé des Gens de Mer" of Boulogne-sur-Mer, fish-processing factory worker followed by the "Service de Santé au Travail" of Boulogne-sur-Mer, or worker followed by the "Service de Santé au Travail" of Boulogne-sur-Mer, but not working in a fish-processing factory. 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

Additional Information

Official title Protists and Nematodes Fish Parasites: From Their Circulation in Ecosystems to Their Impact on Human Health - Prevalence of Fish Allergy in Occupational Settings.
Principal investigator Emmanuel DUTOIT, MD
Description 162 fishermen, 162 fish-processing factory workers, and 162 control subjects will be consecutively recruited by their occupational doctor during a routine consultation. A standardized questionnaire will be used to collect epidemiological and clinical data on potential allergic manifestation resulting from digestive, cutaneous, or respiratory contact with fish. Domestic and occupational risk factors for fish and Anisakis exposure will also be collected for both allergic and non-allergic patients.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University Hospital, Lille.