BACKGROUND: Recent interest in the labeling of foods and food proteins derived from allergenic sources necessitates determination of the potential allergenicity of such food ingredients. Fish gelatin is extracted from the skin of fish species known to elicit allergic reactions in sensitized individuals. OBJECTIVE: To determine the allergenicity of fish gelatin by double-blinded, placebo-controlled food challenges (DBPCFC) in clinically fish-allergic individuals. METHODS:Thirty fish-allergic patients diagnosed according to the EAACI Guidelines were included (age 9-50 years). Skin prick tests (SPT) and Histamine Release tests (HR) were performed with fish gelatin and codfish, and codfish-specific IgE was measured. All patients underwent DBPCFC with a cumulative dose of 14.61 g fish gelatin. RESULTS: In all 30 patients SPT, HR, and specific IgE to codfish were positive. SPT and HR with fish gelatin were positive in 3/30 and 7/30, respectively. One patient showed mild reaction to placebo and no reaction to the active challenge. Two patients reported mild subjective reactions to active challenge. Upon re-challenge one of them described subjective symptoms again to the active challenge (7.61 g cumulated dose of fish gelatin) with no reaction to placebo, while the other experienced very mild subjective symptoms to placebo and nothing to the active. The proportion of truly sensitive patients was estimated to 0.03 in the total study group. CONCLUSION: None of 30 fish allergic patients reacted adversely to the ingestion of 3.61 g cumulative dose of fish gelatin. In this study fish gelatin presents no risk to fish-allergic patients at the doses typically used. Statistically, these results indicate that there is 95% certainty that 90% of fish-allergic consumers will not react to ingestion of a 3.61 g cumulative dose of fish gelatin.
RCT Entities:
BACKGROUND: Recent interest in the labeling of foods and food proteins derived from allergenic sources necessitates determination of the potential allergenicity of such food ingredients. Fish gelatin is extracted from the skin of fish species known to elicit allergic reactions in sensitized individuals. OBJECTIVE: To determine the allergenicity of fish gelatin by double-blinded, placebo-controlled food challenges (DBPCFC) in clinically fish-allergic individuals. METHODS: Thirty fish-allergicpatients diagnosed according to the EAACI Guidelines were included (age 9-50 years). Skin prick tests (SPT) and Histamine Release tests (HR) were performed with fish gelatin and codfish, and codfish-specific IgE was measured. All patients underwent DBPCFC with a cumulative dose of 14.61 g fish gelatin. RESULTS: In all 30 patients SPT, HR, and specific IgE to codfish were positive. SPT and HR with fish gelatin were positive in 3/30 and 7/30, respectively. One patient showed mild reaction to placebo and no reaction to the active challenge. Two patients reported mild subjective reactions to active challenge. Upon re-challenge one of them described subjective symptoms again to the active challenge (7.61 g cumulated dose of fish gelatin) with no reaction to placebo, while the other experienced very mild subjective symptoms to placebo and nothing to the active. The proportion of truly sensitive patients was estimated to 0.03 in the total study group. CONCLUSION: None of 30 fish allergicpatients reacted adversely to the ingestion of 3.61 g cumulative dose of fish gelatin. In this study fish gelatin presents no risk to fish-allergicpatients at the doses typically used. Statistically, these results indicate that there is 95% certainty that 90% of fish-allergic consumers will not react to ingestion of a 3.61 g cumulative dose of fish gelatin.
Authors: Eva Untersmayr; Helle Vestergaard; Hans-Jørgen Malling; Louise Bjerremann Jensen; Michael H Platzer; George Boltz-Nitulescu; Otto Scheiner; Per Stahl Skov; Erika Jensen-Jarolim; Lars K Poulsen Journal: J Allergy Clin Immunol Date: 2007-01-09 Impact factor: 10.793
Authors: Laurian Zuidmeer-Jongejan; Montserrat Fernandez-Rivas; Lars K Poulsen; Angela Neubauer; Juan Asturias; Lars Blom; Joyce Boye; Carsten Bindslev-Jensen; Michael Clausen; Rosa Ferrara; Paula Garosi; Hans Huber; Bettina M Jensen; Stef Koppelman; Marek L Kowalski; Anna Lewandowska-Polak; Birgit Linhart; Bernard Maillere; Adriano Mari; Alberto Martinez; Clare En Mills; Claudio Nicoletti; Dirk-Jan Opstelten; Nikos G Papadopoulos; Antonio Portoles; Neil Rigby; Enrico Scala; Heidi J Schnoor; Sigurveig T Sigurdardottir; George Stavroulakis; Frank Stolz; Ines Swoboda; Rudolf Valenta; Rob van den Hout; Serge A Versteeg; Marianne Witten; Ronald van Ree Journal: Clin Transl Allergy Date: 2012-03-09 Impact factor: 5.871