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Safety of Chitosan as Wine Fining Agent in Shrimp Allergic Patients

NCT02151279 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-05-30

No results posted yet for this study

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.

Conditions

  • Shellfish Allergy

Interventions

OTHER

Chitosan as wine fining agent

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.

OTHER

Control

Sponsors & Collaborators

  • Aveiro University

    collaborator OTHER

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Luís P Amaral, MD · * Intern

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-07-31
Completion
2014-09-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02151279 on ClinicalTrials.gov