Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia
Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
Acid reduction remains the most common treatment prescribed empirically by pediatric
gastroenterologists for children with functional dyspepsia (FD). When acid reduction therapy
fails to provide patients with a therapeutic effect, ketotifen and cromolyn, mast cell
stabilizers, represent an attractive potential therapy given data implicating mast cells in
the generation of dyspeptic symptoms. Although there have been no adult or pediatric studies
on the use of mast cell stabilizers in patients with FD, benefit has been demonstrated in
adults with IBS and children with eosinophilic gastroenteritis. Additionally, previous
studies show mucosal eosinophilia is highly correlated with functional dyspepsia. Our usual
current treatment pathway for functional dyspepsia in association with duodenal mucosal
eosinophilia is as follows: acid-reducing medication/montelukast → addition of H1 antagonist
→ addition of budesonide → addition of oral cromolyn. If ketotifen is effective, it offers
the advantage of being able to replace both the H1 antagonist and the oral cromolyn at a
substantially reduced cost (approximately 10% of the cost of cromolyn alone). This study aims
to introduce ketotifen earlier in the treatment pathway to examine its efficacy on children
with functional dyspepsia in association with duodenal eosinophilia.