Anisakis Blastocystis Cryptosporidium Fish Prevalence

Allergy Clinical Trial

— ABCFish1  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661074
• Other study ID #: 2013_42
• Secondary ID: 2014-A00853-44
• Status: Completed
• Phase: N/A
• First received: January 13, 2016
• Last updated: October 26, 2016
• Start date: November 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergy
• Anisakis
• Hypersensitivity
• Occupational Exposure

Intervention

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.

Locations

Country	Name	City	State
France	Service de Santé des Gens de Mer	Boulogne sur mer
France	Centre ASTIL	Boulogne-sur-Mer
France	CHRU	Lille

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Lille	ANSES, Boulogne-sur-Mer, Institut Pasteur de Lille, Région Nord-Pas de Calais, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Frequencies history of infections Anisakis spp.	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)	No
Secondary	Frequency of fish allergies, history of infections Anisakis spp. (clinical diagnosis)	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)	No
Secondary	history of infections Anisakis spp. (clinical diagnosis)	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)	No
Secondary	Frequency of risk factors for occupational or domestic exposure to fish:	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)	No