Ketotifen for Children with Functional Dyspepsia and Duodenal Eosinophilia
This study is testing if ketotifen, an anti-allergy medication, can help children aged 8-17 who have functional dyspepsia (ongoing stomach pain) and a specific type of inflammation in their small intestine called duodenal eosinophilia. These children have not found relief from standard acid-reducing medicines. The study compares ketotifen to a placebo (an inactive pill) to see if ketotifen can reduce symptoms. To join, children must have had an endoscopy showing more than 20 eosinophils (a type of white blood cell) in their duodenal biopsies. The study aims to see if ketotifen improves symptoms in these children. The current recruitment status is unclear.
- Study design
- This is a double-blind, placebo-controlled, cross-over study with 40 planned participants. This means neither you nor the study staff will know if you are receiving ketotifen or the placebo at first.
- What's involved
- You would have 3 to 4 clinic visits and 2 to 3 phone interviews over 63 to 147 days. Clinic visits include a physical exam, blood draws, questionnaires, and a review of your medical history and medications.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your physical, blood pressure, and liver function will be measured at day 0, day 28, day 63, and day 147.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia
At a glance
Conditions
NCT02484248
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
The Children's Mercy Hospital
Kansas City, Missouristudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Craig A Friesen, MD · PRINCIPAL_INVESTIGATOR · Children's Mercy Hospital Kansas City
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Complete Physicalday 0, day 28, day 63, and day 147
The study physician will check all systems and ask questions about pain and symptoms. This is a comprehensive system check to ensure safety. Change is assessed from each time period.
- Blood pressureday 0, day 28, day 63, and day 147
A trained professional will measure blood pressure to ensure value is within normal range and ensure safety of patient. Change is assessed from each time period.
- Liver Functioning Test (a test ran from a blood sample to check a patients liver functioning)day 0, day 28, day 63, and day 147
A blood sample is collected and tested by a certified laboratory for liver function. This will be completed and verified to be within normal ranges by the study physician to ensure patient safety. Change is assessed from each time period.
- State-Trait Inventory for Cognitive and Somatic Anxiety - Child Versionday 0, day 28, day 63, and day 147
Anxiety score testing assessed with questionnaires. Anxiety scores are correlated with pain. Change is assessed from each time period.
- Pediatric Quality of Life Inventoryday 0, day 28, day 63, and day 147
Quality of life survey for pediatrics to ensures maintenance of quality of life throughout study. Change is assessed from each time period.
- Heart Rateday 0, day 28, day 63, and day 147
A trained professional will measure heart rate to ensure value is within normal range and patient safety. Change is assessed from each time period.
- Respiratory Rateday 0, day 28, day 63, and day 147
A trained professional will measure respiratory rate to ensure value is within normal range and patient safety. Change is assessed from each time period.