Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anisakis Blastocystis Cryptosporidium Fish Prevalence (ABCFish1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02661074
Recruitment Status : Completed
First Posted : January 22, 2016
Last Update Posted : October 27, 2016
Sponsor:
Collaborators:
Institut Pasteur de Lille
ANSES
Région Nord-Pas de Calais, France
Information provided by (Responsible Party):
University Hospital, Lille

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
Anisakis Allergy Occupational Exposure 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.

Layout table for study information
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 : November 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. 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)

  2. 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.


  3. 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.


  4. 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-).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661074


Locations
Layout table for location information
France
Service de Santé des Gens de Mer
Boulogne sur mer, France
Centre ASTIL
Boulogne-sur-Mer, France
CHRU
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Institut Pasteur de Lille
ANSES
Région Nord-Pas de Calais, France
Investigators
Layout table for investigator information
Principal Investigator: Emmanuel DUTOIT, MD University Hospital, Lille

Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02661074     History of Changes
Other Study ID Numbers: 2013_42
2014-A00853-44 ( Other Identifier: ID RCB number, ANSM )
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Lille:
Fisherman
Fish industry

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Anisakiasis
Immune System Diseases
Ascaridida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Intestinal Diseases, Parasitic
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases