Clinical trial NCT02661074: Anisakis Blastocystis Cryptosporidium Fish Prevalence
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anisakis
Allergy
Occupational Exposure
Keywords: Fisherman
Fish industry
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Institut Pasteur de Lille
name: ANSES
name: Région Nord-Pas de Calais, France
First posted: 2016-01-22
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The prevalence of fish allergy
timeFrame: contact by phone during 30 min at only visit (inclusion)
Secondary outcomes:
measure: Frequencies history of infections Anisakis spp.
timeFrame: contact by phone during 30 min at only visit (inclusion)
measure: Frequency of fish allergies, history of infections Anisakis spp. (clinical diagnosis)
timeFrame: contact by phone during 30 min at only visit (inclusion)
measure: history of infections Anisakis spp. (clinical diagnosis)
timeFrame: contact by phone during 30 min at only visit (inclusion)
measure: Frequency of risk factors for occupational or domestic exposure to fish:
timeFrame: contact by phone during 30 min at only visit (inclusion)
Other outcomes:
Locations:
city: Boulogne sur mer
country: France
facility: Service de Santé des Gens de Mer
city: Boulogne-sur-Mer
country: France
facility: Centre ASTIL
city: Lille
country: France
facility: CHRU
Study officials:
affiliation: University Hospital, Lille
name: Emmanuel DUTOIT, MD
role: PRINCIPAL_INVESTIGATOR
References: