NCT02661074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
486

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

January 13, 2016

Last Update Submit

October 26, 2016

Conditions

Keywords

FishermanFish industry

Outcome Measures

Primary Outcomes (1)

  • The prevalence of fish allergy

    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 Outcomes (4)

  • Frequencies history of infections Anisakis spp.

    contact by phone during 30 min at only visit (inclusion)

  • Frequency of fish allergies, history of infections Anisakis spp. (clinical diagnosis)

    contact by phone during 30 min at only visit (inclusion)

  • history of infections Anisakis spp. (clinical diagnosis)

    contact by phone during 30 min at only visit (inclusion)

  • Frequency of risk factors for occupational or domestic exposure to fish:

    contact by phone during 30 min at only visit (inclusion)

Study Arms (3)

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

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

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

Interventions

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.

ControlFish processing factoriesFishermen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre ASTIL

Boulogne-sur-Mer, France

Location

Service de Santé des Gens de Mer

Boulogne-sur-Mer, France

Location

CHRU

Lille, France

Location

MeSH Terms

Conditions

AnisakiasisHypersensitivity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Ascaridida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfectionsIntestinal Diseases, ParasiticIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Emmanuel DUTOIT, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 22, 2016

Study Start

November 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations