Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia

Inclusion Criteria: 1. between the ages of 8 and 17 years, inclusive 2. abdominal pain of at least 8 weeks duration and fulfilling symptom-based criteria for functional dyspepsia(5); 3. previous endoscopy with biopsies demonstrating \>20 eosinophils/high powered field on duodenal mucosal biopsies; 4. previous treatment with acid-reduction therapy and montelukast with a level 3 (as defined below)or lesser response; 5. evidence of written parental permission (consent) and subject assent; 6. Negative pregnancy screening for females of child bearing potential. Exclusion Criteria: 1. previous treatment with ketotifen; 2. treatment with oral corticosteroids or oral cromolyn sodium in the 6 months prior to enrollment; 3. any prior history of diabetes mellitus, cancer, chronic cardiac disease, respiratory disease, or renal disease requiring routine medical care; 4. Pregnant/planning to become pregnant; 5. Post-menarche females unwilling to use highly-efficacious contraception to prevent pregnancy; 6. Epilepsy or history of seizures; 7. Liver disease or elevation of liver enzymes; 8. Use of oral hypoglycemic medications, antipsychotics, benzodiazepines, tricyclic antidepressants, barbiturates, or opioids; 9. Allergy to ketotifen or other products in capsule 10. Refusal of Urine pregnancy test in post-menarchal females.