Safety of Chitosan as Wine Fining Agent in Shrimp Allergic Patients
SWAP
1 other identifier
interventional
15
1 country
2
Brief Summary
Chitosan, the main component of the exoskeletons of crustaceans, mollusks and cephalopods, has been used as a fining agent in wines. However, its safety among patients allergic to shellfish has never been evaluated. Adult patients followed at the Allergy and Clinical Immunology Department who have been diagnosed with anaphylaxis to shrimp will be invited to participate in the study. Clinical data will be collected to ascertain for eligibility and written information will be provided. After signing informed consent, included subjects will perform skin prick-to-prick tests (PTP) with shrimp boiling water condensate and with fined and unfined wines. All will perform double blind oral challenge with the fined and unfined wines during 1visit day; the placebo (unfined wine) and active challenge (fined wine with chitosan) will be separated by 2 hours. Challenge protocol will be performed with successive increasing doses administered in 4 steps at 15-minute intervals for a total of 100 mL. During the challenge signs and symptoms will be monitored by a trained physician. Results will be presented as negative or positive (defined by presence of symptoms and signs of an allergic reaction). Categorical data will be compared by chi-square test. P\<0.05 will be considered statistically significant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2014
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 20, 2014
CompletedFirst Posted
Study publicly available on registry
May 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMay 30, 2014
May 1, 2014
4 months
May 20, 2014
May 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events to a Double Blind Placebo Controlled Food Challenge with chitosan fined wine
Participants will be followed until one to two hours after the end of the Food Challenge, an expected average of 6 to 8 hours
Study Arms (2)
control group
PLACEBO COMPARATORChitosan as wine fining agent
Shrimp allergic patients
ACTIVE COMPARATORChitosan as wine fining agent
Interventions
The possibility of allergic reactions attributed to traces of chitosan used as a fining agent in wine has not been ruled out, particularly in shrimp allergic patients to whom small traces of the potential allergen may be enough to trigger anaphylactic reactions.
Eligibility Criteria
You may qualify if:
- Aged above 18 and less than 65 years
- Willing to comply with all study procedures and available for the duration of the study;
- Diagnosed with shrimp allergy, based on clinical history, plus positive skin tests and/or positive IgE;
- Previous anaphylactic reaction to shrimp;
- Either sex and of any race
- Provide signed and dated informed consent form
You may not qualify if:
- Dermatological disease which precludes or alters the results of skin tests
- History of wine/alcohol intolerance
- Acquired or hereditary immunodeficiency
- Neoplasia
- Psychiatric disease
- FEV1\<70%
- Taking any systemic medication that might interfere with the study and that is not possible to withdraw, namely oral corticosteroids or immunomodulators in the last 4 weeks, or antihistamines in the last 10 days
- Under beta-blockers or ACE inhibitors
- Presence of any significant illness that could interfere with the study or alter its results or increase the risk of anaphylaxis, such as systemic mastocytosis
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade do Portolead
- Aveiro Universitycollaborator
Study Sites (2)
Universidade de Aveiro
Aveiro, Portugal
Serviço de Imunoalergologia Hospital São João
Porto, 4200-239, Portugal
Related Publications (1)
Amaral L, Silva D, Couto M, Nunes C, Rocha SM, Coimbra MA, Coimbra A, Moreira A. Safety of chitosan processed wine in shrimp allergic patients. Ann Allergy Asthma Immunol. 2016 May;116(5):462-3. doi: 10.1016/j.anai.2016.02.004. Epub 2016 Mar 19. No abstract available.
PMID: 27009439DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luís P Amaral, MD
* Intern
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2014
First Posted
May 30, 2014
Study Start
March 1, 2014
Primary Completion
July 1, 2014
Study Completion
September 1, 2014
Last Updated
May 30, 2014
Record last verified: 2014-05