Clinical Trial: Anisakis Blastocystis Cryptosporidium Fish Serology

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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.

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).

Detailed Summary: 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.
Sponsor: University Hospital, Lille

Current Primary Outcome: 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) ]

Original Primary Outcome: the frequency of anti-Anisakis and/or anti-fish IgE [ Time Frame: contact by phone during 30 min at only visit (inclusion) ]

Current Secondary Outcome:

• 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.
• 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) ]
• 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.
• 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.
• 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.

Original Secondary Outcome:

• anti-Anisakis and/or anti-fish IgE level [ 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.
• the frequency of anti-Anisakis and anti-fish IgEin patients with fish allergy [ Time Frame: contact by phone during 30 min at only visit (inclusion) ]
• the prevalence 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.
• 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.
• The frequency of domestic exposure to fish parasites antigens [ 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.

Information By: University Hospital, Lille

Dates:
Date Received: January 25, 2016
Date Started: February 2015
Date Completion:
Last Updated: January 17, 2017
Last Verified: January 2017