AnisakisABCFish1NCT02661074
Anisakis Blastocystis Cryptosporidium Fish Prevalence
An observational study of Anisakis and Allergy, run by University Hospital, Lille at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anisakis, Allergy, Occupational Exposure
- What is being tested?
- Questionnaire
- How many people
- 486 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2014to Oct 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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
3 sites in 1 country.
France3 sites
Centre ASTIL
Boulogne-sur-Mer
Service de Santé des Gens de Mer
Boulogne-sur-Mer
CHRU
Lille
About this study
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.
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.
Read the 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.
- Conditions
- Anisakis, Allergy, Occupational Exposure
- Being tested
- Questionnaire
- Keywords
- Fisherman, Fish industry
- Medical subject headings
- Anisakiasis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire | |
| 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. Receives: Other: Questionnaire | |
| 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. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of fish allergy
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)
Measured: contact by phone during 30 min at only visit (inclusion)
Secondary outcomes (4)
Frequencies history of infections Anisakis spp.
Comparison between occupationally exposed ( E: fishermen and fish-processing factory workers) and non-exposed subjects(NE)
Measured: contact by phone during 30 min at only visit (inclusion)
Frequency of fish allergies, history of infections Anisakis spp. (clinical diagnosis)
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.
Measured: contact by phone during 30 min at only visit (inclusion)
history of infections Anisakis spp. (clinical diagnosis)
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.
Measured: contact by phone during 30 min at only visit (inclusion)
Frequency of risk factors for occupational or domestic exposure to fish:
comparison subjects (i) allergic or non-allergic Fish (APC + APC-vs) (ii) with or without a history of infection Anisakis spp. (IA + vs IA-).
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 posted22 Jan 2016 (estimated)
- Study startNov 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnisakisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur de Lille, ANSES, 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
- NCT02661074
- Sponsor's protocol ID
- 2013_42
- Other IDs
- 2014-A00853-44
- Acronym
- ABCFish1
- Status last verified
- Oct 2016
- First submitted
- 13 Jan 2016
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yera H, Frealle E, Dutoit E, Dupouy-Camet J. A national retrospective survey of anisakidosis in France (2010-2014): decreasing incidence, female predominance, and emerging allergic potential. Parasite. 2018;25:23. doi: 10.1051/parasite/2018016. Epub 2018 Apr 11.
PubMed 29637891
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. 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 - Prevalence of Fish Allergy in Occupational Settings.
- ClinicalTrials.gov ID
- NCT02661074
- Acronym / sponsor ID
- ABCFish1 / 2013_42
- Conditions
- Anisakis, Allergy, Occupational Exposure
- Keywords
- Fisherman, Fish industry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Institut Pasteur de Lille, ANSES, Région Nord-Pas de Calais, France
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 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 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fishermen | – | Other: QuestionnaireFisherman followed by the "Service de Santé des Gens de Mer" of Boulogne-sur-Mer, France (occupational exposure to fish). A questionnaire will be completed. |
| Fish processing factories | – | Other: QuestionnaireWorkers 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. |
| Control | – | Other: QuestionnaireWorkers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| QuestionnaireA 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. | Other | Control, Fish processing factories, Fishermen |
Primary outcome
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)
4 secondary outcomes
Frequencies history of infections Anisakis spp.
Time frame: contact by phone during 30 min at only visit (inclusion)
Frequency of fish allergies, history of infections Anisakis spp. (clinical diagnosis)
Time frame: contact by phone during 30 min at only visit (inclusion)
history of infections Anisakis spp. (clinical diagnosis)
Time frame: contact by phone during 30 min at only visit (inclusion)
Frequency of risk factors for occupational or domestic exposure to fish:
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 14 May 2026.
- Results publication: PubMed 29637891Yera H, Frealle E, Dutoit E, Dupouy-Camet J. A national retrospective survey of anisakidosis in France (2010-2014): decreasing incidence, female predominance, and emerging allergic potential. Parasite. 2018;25:23. doi: 10.1051/parasite/2018016. Epub 2018 Apr 11.
- Individual participant dataSharing planned: No
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anisakis and Allergy, run by University Hospital, Lille at 3 sites 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 1 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 prevalence of fish allergy (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?
On the ClinicalTrials.gov record for NCT02661074, which also lists 1 linked publication.
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 14 May 2026.