Anisakis Blastocystis Cryptosporidium Fish Prevalence (ABCFish1)

October 26, 2016 updated by: University Hospital, Lille

Protists and Nematodes Fish Parasites: From Their Circulation in Ecosystems to Their Impact on Human Health - Prevalence of Fish Allergy in Occupational Settings.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

486

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne sur mer, France
        • Service de Santé des Gens de Mer
      • Boulogne-sur-Mer, France
        • Centre ASTIL
      • Lille, France
        • CHRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population will include the following 3 groups:

  • Fishermen followed by the "Service de Santé des Gens de Mer" of Boulogne-sur-Mer,
  • Fish-processing factory workers followed by the "Service de Santé au Travail" of Boulogne-sur-Mer,
  • A control group composed of workers followed by the "Service de Santé au Travail" of Boulogne-sur-Mer, but not working in a fish-processing factory.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of fish allergy
Time Frame: 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)
contact by phone during 30 min at only visit (inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequencies history of infections Anisakis spp.
Time Frame: 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)
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)

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.
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)

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.
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)
comparison subjects (i) allergic or non-allergic Fish (APC + APC-vs) (ii) with or without a history of infection Anisakis spp. (IA + vs IA-).
contact by phone during 30 min at only visit (inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

January 18, 2016

First Posted (Estimate)

January 22, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013_42
  • 2014-A00853-44 (Other Identifier: ID RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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