Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Food Protein-induced Enterocolitis Syndrome
• Age: Between 1 Year(s) - 60 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Provision of appropriate consent and/or assent
  2. Age 1-60 years
  3. Suspected or confirmed FPIES diagnosis
  4. Individuals of childbearing potential practicing sexual abstinence or using effective methods of contraception during study participation
  5. English-speaking

  
  

You may not be eligible for this study if the following are true:

• 1. Past severe FPIES defined as hospitalization due to an acute FPIES reaction with neurological compromise or requiring life support
  2. Acute FPIES reaction in the past 6 months
  3. Frequent gastrointestinal symptoms: nausea, abdominal pain, reflux, heartburn, emesis, diarrhea, constipation
  4. Current active eosinophilic gastrointestinal disorders, inflammatory bowel disease, gastroesophageal reflux disease, or any other chronic gastrointestinal condition
  5. Poorly controlled or severe asthma/wheezing
  6. IgE-mediated food allergies where the trigger has not been identified
  7. Inability to discontinue oral antihistamines, short-acting bronchodilators, beta-blockers, ACE inhibitors, and/or proton pump inhibitors for 7 days prior to the screening visit
  8. Personal or family history of prolonged QT syndrome
  9. Personal history of arrhythmia
  10. Current diagnosis of
      • arterial hypertension
      • cardiovascular disease
      • any chronic autoimmune disease
      • liver disease
  11. Primary or secondary immunodeficiency
  12. Phenylketonuria (PKU)
  13. Use of systemic steroids within 30 days of screening
  14. Chemotherapy, radiotherapy, or any systemic immunosuppressive drugs in the past 12 months
  15. Use of biologic drugs or allergen-specific immunotherapy by any route in the past 12 months
  16. Inability to defer routine immunizations or passive immunization with immune globulin for the duration of participation in the study
  17. Allergy to any of the following medications: ondansetron (Zofran), dolasetron (Azemet), granisetron (Kytril), or palonosetron (Aloxi)
  18. Pregnancy or breastfeeding