ABCFish1: Anisakis Blastocystis Cryptosporidium Fish Prevalence

Sponsor
University Hospital, Lille (Other)
Overall Status
Completed
CT.gov ID
NCT02661074
Collaborator
Institut Pasteur de Lille (Other), ANSES (Other), Région Nord-Pas de Calais, France (Other)
486
3
23
162
7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
486 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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.
Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Fishermen

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.

Other: 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.

Fish processing factories

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.

Other: 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.

Control

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. The prevalence of fish allergy [contact by phone during 30 min at only visit (inclusion)]

    Difference in the prevalence of fish allergy between occupationally exposed (fishermen and fish-processing factory workers) and non-exposed subjects. the fish allergy is definied by clinical diagnosis based on the presence of clinical manifestations of allergy in contact with the fish ( APC)

Secondary Outcome Measures

  1. Frequencies history of infections Anisakis spp. [contact by phone during 30 min at only visit (inclusion)]

    Comparison between occupationally exposed ( E: fishermen and fish-processing factory workers) and non-exposed subjects(NE)

  2. Frequency of fish allergies, history of infections Anisakis spp. (clinical diagnosis) [contact by phone during 30 min at only visit (inclusion)]

    comparison between occupationally exposed and non-exposed subjects for previous Anisakidosis. Fish exposure will be determined taking into account the handled fish species and the local prevalences of fish parasites.

  3. history of infections Anisakis spp. (clinical diagnosis) [contact by phone during 30 min at only visit (inclusion)]

    comparison between occupationally exposed and non-exposed subjects for previous Anisakidosis. Fish exposure will be determined taking into account the handled fish species and the local prevalences of fish parasites.

  4. Frequency of risk factors for occupational or domestic exposure to fish: [contact by phone during 30 min at only visit (inclusion)]

    comparison subjects (i) allergic or non-allergic Fish (APC + APC-vs) (ii) with or without a history of infection Anisakis spp. (IA + vs IA-).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de Santé des Gens de Mer Boulogne sur mer France
2 Centre ASTIL Boulogne-sur-Mer France
3 CHRU Lille France

Sponsors and Collaborators

  • University Hospital, Lille
  • Institut Pasteur de Lille
  • ANSES
  • Région Nord-Pas de Calais, France

Investigators

  • Principal Investigator: Emmanuel DUTOIT, MD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT02661074
Other Study ID Numbers:
  • 2013_42
  • 2014-A00853-44
First Posted:
Jan 22, 2016
Last Update Posted:
Oct 27, 2016
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University Hospital, Lille
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2016