Allergy to Mold Clinical Trial
Official title:
Evaluation of the Potential of Air Structuring Protein, a Novel Protein Preparation Derived From Trichoderma Reesei, to Elicit Allergic Reactions in Mold Sensitized People
Air Structuring Protein (ASP) is a small protein derived from a fungus which is already
widely used to produce enzymes that are added to foods. ASP has the possibility of
stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential
ice-cream ingredient.
Toxicological tests have also been carried out to further confirm the safety of the material
and no evidence of genotoxicity or acute toxicity has been observed in any of the tests.
As part of the safety evaluation of a new protein for use in foods, the potential
allergenicity is also investigated and Unilever is sponsoring a study to evaluate this
aspect of ASP. This study will investigate:
- Whether ASP has the potential to elicit a positive skin prick test (SPT) in a
population of participants with proven sensitivity to mould.
- Whether ASP is responsible for any positive SPT reactions, should they occur.
- And if any positive SPT reactions to ASP occur, whether such reactions are clinically
relevant with respect to food allergy.
The study is divided in three stages. In Stage 1 and Stage 2, the SPT is "open label," which
means that both the participant and the study doctor will know which materials are being
tested.
In Stage 3, the food challenge has a "crossover" design, meaning that participants will take
one of the products (ASP or placebo [food containing no ASP]) during the first half of the
study and the other treatment during the second half. The order of ASP and placebo will be
decided randomly, like tossing a coin. To make the comparison between ASP and placebo as
fair as possible, the food challenge is "double blinded." This means that neither the
participant nor the study doctor will know which kind of products (ASP or placebo) the
participant is taking.
This is a multi centre study which is taking place in the UK.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label