Anisakis Blastocystis Cryptosporidium Fish Serology

NCT02666092 | Completed

• 2 other identifiers: 2013_432014-A00855-42
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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).

Conditions

Allergy to Fish; Allergy; Anisakis

Keywords

IgE; Immunoelectrophoresis; Western Blot; ImmunoCAP

Outcome Measures

Primary Outcomes (1)

• the frequency of anti-Anisakis and/or anti-fish IgE by serum analysis

  comparison between subjects with fish allergy and a matched control population, presenting no fish allergy.

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

Secondary Outcomes (5)

• anti-Anisakis and/or anti-fish IgE level by serum analysis

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

• the frequency of anti-Anisakis and anti-fish IgE in patients with fish allergy by serum analysis

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

• nomber of subjects of previous Anisakidae infections

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

• Measure of the performances of serological tests

  at work medical visit (inclusion)

• The frequency of domestic exposure to fish parasites antigens by questionnaire

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

Study Arms (2)

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; Biological: Detection of anti-Anisakis and anti-fish antibodies

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; Biological: Detection of anti-Anisakis and anti-fish antibodies

Interventions

Questionnaire OTHER

Questionnaire on domestic exposure to fish, and, for patients with fish allergy, on the characteristics of clinical manifestations)

Control; Fish allergy

Detection of anti-Anisakis and anti-fish antibodies BIOLOGICAL

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

Control; Fish allergy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Institut Pasteur de Lille: collaborator
• ANSES: collaborator
• Hôpital Cochin: collaborator
• Région Nord-Pas de Calais, France: collaborator

Study Sites (1)

CHRU

Lille, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Hypersensitivity; Anisakiasis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Immune System Diseases; Ascaridida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Intestinal Diseases, Parasitic; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Emmanuel DUTOIT, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: February 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)