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Anisakis Blastocystis Cryptosporidium Fish Serology (ABCFish2)

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ClinicalTrials.gov Identifier: NCT02666092
Recruitment Status : Completed
First Posted : January 28, 2016
Last Update Posted : January 18, 2017
Sponsor:
Collaborators:
Institut Pasteur de Lille
ANSES
Hôpital Cochin
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 diseases 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 allergic symptoms can also occur in isolation, after ingestion of Anisakidae antigens contained in raw or cooked fish, and may masquerade as fish allergy.

In this study, we aim to characterize the relationship between Anisakidae and/or fish sensitization and the presence of allergic manifestations in patients recruited in the general population and presenting fish allergy resulting from ingestion, cutaneous or respiratory contact. We will also determine the respective role of Anisakidae or fish sensitization in patients with fish allergy. Then, we will determine the prevalence of previous Anisakidae infections among these patients and a matched control population. We will also compare the performances of serological tests (ImmunoCAP, immunoelectrophoresis and Western Blot) for the diagnosis of Anisakidae allergy or infection. Lastly, we will explore the relationship between domestic exposure to Anisakidae or fish antigens and the occurrence of associated pathologies (Anisakidae or fish allergy/sensitization; Anisakidae infection).


Condition or disease Intervention/treatment
Allergy to Fish Allergy Anisakis Other: Questionnaire Biological: Detection of anti-Anisakis and anti-fish antibodies

Detailed Description:
First, 51 patients with fish allergy will be recruited from the Parasitology-Mycology and Immunology Laboratories of Lille University Hospital databases (serology for anti-Anisakis or anti-fish detection). Then, clinical (characteristics of allergic manifestations) and epidemiological (domestic exposure to fish) data will be collected, and anti-fish or Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), or ImmunoCAP, immunoelectrophoresis, Western Blot, respectively. Similar serological tests will be performed for a control group of 51 matched subjects who will be recruited among Lille University Hospital workers.

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Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Protists and Nematodes Fish Parasites: From Their Circulation in Ecosystems to Their Impact on Human Health - Role of Anisakidae and/or Fish Flesh Antigens in Fish Allergies.
Study Start Date : February 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
Fish allergy

51 subjects presenting allergic manifestations after digestive, cutaneous, or respiratory contact with fish will be recruited.

Interventions will include:

  • A questionnaire on domestic exposure to fish, and on the characteristics of clinical manifestations
  • A detection of anti-Anisakis and anti-fish antibodies
Other: Questionnaire
Questionnaire on domestic exposure to fish, and, for patients with fish allergy, on the characteristics of clinical manifestations)

Biological: Detection of anti-Anisakis and anti-fish antibodies
Anti-fish IgE will be detected using ImmunoCAP. Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), immunoelectrophoresis (precipitins) and Western Blot.

Control

51 subjects presenting no allergic manifestations after contact with fish.

Interventions will include:

  • A questionnaire on domestic exposure to fish
  • A detection of anti-Anisakis and anti-fish antibodies
Other: Questionnaire
Questionnaire on domestic exposure to fish, and, for patients with fish allergy, on the characteristics of clinical manifestations)

Biological: Detection of anti-Anisakis and anti-fish antibodies
Anti-fish IgE will be detected using ImmunoCAP. Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), immunoelectrophoresis (precipitins) and Western Blot.




Primary Outcome Measures :
  1. the frequency of anti-Anisakis and/or anti-fish IgE by serum analysis [ Time Frame: contact by phone during 30 min at only visit (inclusion) ]
    comparison between subjects with fish allergy and a matched control population, presenting no fish allergy.


Secondary Outcome Measures :
  1. anti-Anisakis and/or anti-fish IgE level by serum analysis [ Time Frame: contact by phone during 30 min at only visit (inclusion) ]
    Comparison between subjects with fish allergy and a matched control population, presenting no fish allergy.

  2. the frequency of anti-Anisakis and anti-fish IgE in patients with fish allergy by serum analysis [ Time Frame: contact by phone during 30 min at only visit (inclusion) ]
  3. nomber of subjects of previous Anisakidae infections [ Time Frame: contact by phone during 30 min at only visit (inclusion) ]
    questionnaire-based diagnosis, supported by serological testing between patients with fish allergy and a matched control population, presenting no fish allergy.

  4. Measure of the performances of serological tests [ Time Frame: at work medical visit (inclusion) ]
    Comparison of the performances of serological tests (ImmunoCAP, immunoelectrophoresis and Western Blot) for the diagnosis of Anisakidae allergy or infection.

  5. The frequency of domestic exposure to fish parasites antigens by questionnaire [ Time Frame: contact by phone during 30 min at only visit (inclusion) ]

    It will be compared between Anisakis or fish allergic/sensitized subjects and non-allergic/non sensitized subjects.

    It will be compared between patients with or without previous Anisakidosis. Fish exposure will be determined taking into account the handled fish species and the local prevalences of fish parasites.



Biospecimen Retention:   Samples Without DNA
Serum samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The recruited population will include:

  • 51 patients with fish allergy
  • 51 matched control subjects (sex, age +/- 5 years)
Criteria

Inclusion Criteria:

ALLERGIC PATIENTS:

  • Previous serological assessment for anti-Anisakis or anti-fish antibodies detection (ImmunoCap and/or immunoelectrophoresis) in Lille University Hospital Center, and volume of serum conserved ≥500 µl
  • Allergic manifestations after contact with fish (asthma, allergic rhinitis, conjunctivitis, chronic or acute urticaria, dermatitis/eczema, eosinophilic gastroenteritis, gingivostomatitis, angioedema, bronchospasm, anaphylaxis)

CONTROL SUBJECTS:

  • Serological assessment for infectious disease during a routine occupational health consultation in Lille University Hospital Center
  • Absence of fish allergy

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): NCT02666092


Locations
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France
CHRU
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Institut Pasteur de Lille
ANSES
Hôpital Cochin
Région Nord-Pas de Calais, France
Investigators
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Principal Investigator: Emmanuel DUTOIT, MD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02666092     History of Changes
Other Study ID Numbers: 2013_43
2014-A00855-42 ( Other Identifier: ID RCB number, ANSM )
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Lille:
IgE
Immunoelectrophoresis
Western Blot
ImmunoCAP

Additional relevant MeSH terms:
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Hypersensitivity
Anisakiasis
Immune System Diseases
Ascaridida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Intestinal Diseases, Parasitic
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs