An official website of the United States government.
<OL> <LI> To determine if peanut proteins (intact and digested peptides) are detectable in the saliva and serum of normal subjects who are fed peanut flour. If detected, the level of peanut protein may be of importance in explaining reactions of peanut allergic individuals when kissed by their partner or come in contact with saliva hours after eating peanut-containing foods. <LI>The other objective of this study is so to see if allergenic peanut proteins can be tracked through the blood serum over time after ingestion; these results can give information as to how peanut allergens travel in the blood, perhaps migrating to breast milk and sensitizing babies to peanut as has been shown for cows' milk protein.
Non-Technical Summary: No one yet knows how allergenic proteins make their way into breast milk or saliva and can cause young children to become food-allergic. This purpose of this study is to monitor the travel of allergenic proteins into saliva and blood serum to give clues as to how babies can be come sensitized to allergic foods at a very young age. New information from this study will assist in development of improved diagnostic and therapeutic treatments for food allergy. <P> Approach: Ten adult subjects will be orally challenged by consuming 25 grams of peanut flour in capsules. Blood samples for serum recovery and saliva will be collected at specified time points over a 24 hour period. Serum and saliva will be analyzed to determine the presence of peanut proteins (intact and digested peptides). Serum and saliva will be collected at the same time points from two adult subjects who will not be orally challenged with peanut flour and serve as negative controls. Saliva samples will be collected at time points 0.5, 1, 2, 3, 4, 6, 8 and 24 hours at the clinical study locale. Subjects will collect saliva off-site at the 10, 12 and 14 hour time points with supplied tubes. Food, drink (including water) and oral hygiene practices should be avoided 30 minutes before the saliva collection time points. Saliva will be collected over a 5 minute period for each time point. Subjects will be instructed to produce saliva by making chewing motions with the mouth and spitting the resulting saliva into a 50 mL sterile conical tube whenever the subject feels the need to spit. This should continue for 5 minutes resulting in 4-8 mL of saliva. The saliva sample should be capped and frozen immediately after collection. Subjects will freeze the samples collected off site and bring them to the clinical study site the next morning, where the final saliva sample at the 24 time point will be collected. Serum and saliva samples will be analyzed by two enzyme linked immunosorbent assays (ELISA) to detect peanut proteins/allergens. Intact peanut protein will be detected using a commercially available assay from Neogen Corporation (Veratox r for Peanut Allergen). The digestion-resistant peptide of peanut allergen Ara h 2 will be detected using an ELISA that has been developed in our lab.