Allergy to FishABCFish2NCT02666092
Anisakis Blastocystis Cryptosporidium Fish Serology
An observational study of Allergy to Fish and Allergy, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy to Fish, Allergy, Anisakis
- What is being tested?
- Questionnaire and Detection of anti-Anisakis and anti-fish antibodies
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The recruited population will include: * 51 patients with fish allergy * 51 matched control subjects (sex, age +/- 5 years)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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.
- Conditions
- Allergy to Fish, Allergy, Anisakis
- Being tested
- Questionnaire, Detection of anti-Anisakis and anti-fish antibodies
- Keywords
- IgE, Immunoelectrophoresis, Western Blot, ImmunoCAP
- Medical subject headings
- Hypersensitivity, Anisakiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire on domestic exposure to fish, and, for patients with fish allergy, on the characteristics of clinical manifestations)
Detection of anti-Anisakis and anti-fish antibodiesBiological
Anti-fish IgE will be detected using ImmunoCAP. Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), immunoelectrophoresis (precipitins) and Western Blot.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Questionnaire; Biological: Detection of anti-Anisakis and anti-fish antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: contact by phone during 30 min at only visit (inclusion)
Secondary outcomes (5)
anti-Anisakis and/or anti-fish IgE level by serum analysis
Comparison between subjects with fish allergy and a matched control population, presenting no fish allergy.
Measured: 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
Measured: contact by phone during 30 min at only visit (inclusion)
nomber of subjects of previous Anisakidae infections
questionnaire-based diagnosis, supported by serological testing between patients with fish allergy and a matched control population, presenting no fish allergy.
Measured: contact by phone during 30 min at only visit (inclusion)
Measure of the performances of serological tests
Comparison of the performances of serological tests (ImmunoCAP, immunoelectrophoresis and Western Blot) for the diagnosis of Anisakidae allergy or infection.
Measured: at work medical visit (inclusion)
The frequency of domestic exposure to fish parasites antigens by questionnaire
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.
Measured: contact by phone during 30 min at only visit (inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startFeb 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to FishStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur de Lille, ANSES, Hôpital Cochin, Région Nord-Pas de Calais, France
- Responsible party
- Sponsor
- Investigators
- Emmanuel DUTOIT, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666092
- Sponsor's protocol ID
- 2013_43
- Other IDs
- 2014-A00855-42
- Acronym
- ABCFish2
- Status last verified
- Jan 2017
- First submitted
- 25 Jan 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02666092
- Acronym / sponsor ID
- ABCFish2 / 2013_43
- Conditions
- Allergy to Fish, Allergy, Anisakis
- Keywords
- IgE, Immunoelectrophoresis, Western Blot, ImmunoCAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Institut Pasteur de Lille, ANSES, Hôpital Cochin, Région Nord-Pas de Calais, France
- Study start
- Feb 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish allergy | – | Other: Questionnaire, Biological: Detection of anti-Anisakis and anti-fish antibodies51 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 |
| Control | – | Other: Questionnaire, Biological: Detection of anti-Anisakis and anti-fish antibodies51 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The recruited population will include: * 51 patients with fish allergy * 51 matched control subjects (sex, age +/- 5 years)
Key inclusion criteria (6 listed)
- 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)
- Serological assessment for infectious disease during a routine occupational health consultation in Lille University Hospital Center
- Absence of fish allergy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire on domestic exposure to fish, and, for patients with fish allergy, on the characteristics of clinical manifestations) | Other | Control, Fish allergy |
| Detection of anti-Anisakis and anti-fish antibodiesAnti-fish IgE will be detected using ImmunoCAP. Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), immunoelectrophoresis (precipitins) and Western Blot. | Biological | Control, Fish allergy |
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)
comparison between subjects with fish allergy and a matched control population, presenting no fish allergy.
5 secondary outcomes
anti-Anisakis and/or anti-fish IgE level by serum analysis
Time frame: 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
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)
Measure of the performances of serological tests
Time frame: at work medical visit (inclusion)
The frequency of domestic exposure to fish parasites antigens by questionnaire
Time frame: contact by phone during 30 min at only visit (inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel DUTOIT, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy to Fish and Allergy, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.