Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia

Launched by CHILDREN'S MERCY HOSPITAL KANSAS CITY · Jun 24, 2015

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called ketotifen for children aged 8 to 17 who have a condition known as functional dyspepsia (FD), which involves symptoms like stomach pain and discomfort after eating. The trial specifically focuses on children who also show a high number of certain immune cells called eosinophils in their intestines, which may be linked to their symptoms. Many children currently receive acid-reducing medications for FD, but when these treatments don't work, ketotifen could offer a new approach. This study aims to see if starting ketotifen earlier in the treatment process can help improve symptoms more effectively and at a lower cost than the current treatments.

To participate, children must have had stomach pain for at least 8 weeks, have undergone an endoscopy that showed elevated eosinophils in their intestines, and have tried other treatments without much success. Parents will need to give permission for their child to join, and participants will be closely monitored throughout the study. This trial is currently recruiting participants, and it could pave the way for better treatment options for children suffering from functional dyspepsia.

Gender

ALL

Eligibility criteria

• 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.