GI Alpha-Gal Study

Inclusion Criteria:

• The subject is at least 18 years of age.

• The subject has a history of gastrointestinal alpha-gal allergy defined by elevatedtest for α-gal allergy (α-gal IgE >0.1 U/L) due to complaints of either abdominalpain or discomfort, diarrhea, nausea with or without vomiting, or a combination ofthose complaints, within the last 5 years. The subjects must have experienced one ormore of the four symptoms at least once monthly for at least two months. Thesubjects will fill out a symptom questionnaire of the presence of these foursymptoms (abdominal pain or discomfort, diarrhea, nausea, vomiting), frequency andseverity (mild, moderate, or severe) for the 3 months prior to diagnosis.

• The subject has experienced symptomatic improvement on a mammalian meat-free dietover at least a month's time, defined by saying "yes" to the following question: "Onthe alpha-gal avoidant diet, have you had adequate relief of gastrointestinalsymptoms?"

• The subject has elevated α-gal IgE titer on screening for the trial if they do nothave a positive titer within 3 months of enrollment.

• The subject is willing to not take nonsteroidal anti-inflammatory medications,leukotriene modifiers or steroids 14 days prior to challenge.

• The subject is willing to sign the informed consent form.

Exclusion Criteria:

• The subject has health conditions that would pose a significant threat in the faceof anaphylaxis or treatment for anaphylaxis (e.g., cardiac disease, unstable anginapectoris, arrhythmias).

• The subject is allergic to mannitol.

• If female, the subject is pregnant.

• The subject has a history of chronic GI conditions, including inflammatory boweldisease, celiac disease, chronic pancreatitis with continued symptoms (experiencemoderate-severe abdominal pain, diarrhea, or nausea/vomiting that occur morefrequently than once weekly)

• The subject has diarrhea (one or more loose stools that conform to the container),moderate to severe abdominal pain, or vomiting within 10 days prior to thechallenge.

• The subject has a history of severe allergic reaction on mammalian meat ingestion (respiratory distress, chest pain or cardiopulmonary compromise)

• The subject is unwilling to receive intramuscular epinephrine.

• The subject is anticipated to use omalizumab within 6 months of enrollment.

• The subject is anticipated to use systemic steroids within 28 days of foodchallenge.

• The subject is anticipated to use leukotriene modifier within 14 days of foodchallenge.

• The subject is unable to not use nonsteroidal anti-inflammatory drugs for 14 daysprior to challenge.

Additional Exclusion Criteria for Subjects Undergoing Transnasal Endoscopy and Biopsy

• Known conditions that are contraindications to transnasal endoscopy, or in theopinion of the investigator any condition that would interfere with the studyobjectives.

• History of head and neck malignancy or anatomical deformities of the nasopharynx

• Severe anxiety