Safety of Chitosan as Wine Fining Agent in Shrimp Allergic Patients (NCT02151279) | Clinical Trial Compass
UnknownNot Applicable
Safety of Chitosan as Wine Fining Agent in Shrimp Allergic Patients
Portugal15 participantsStarted 2014-03
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events to a Double Blind Placebo Controlled Food Challenge with chitosan fined wine
Timeframe: Participants will be followed until one to two hours after the end of the Food Challenge, an expected average of 6 to 8 hours