NCT02484248 · Craig A. Friesen, MD
Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia
(Ketotifen)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Ketotifen
Ketotifen is an anti-histamine approved by the U.S. FDA to prevent and treat itching of the eyes caused by allergies.
DRUG
Placebo
The placebo tablet looks identical to the ketotifen tablet, but does not contain ketotifen.
Primary outcome measures
Complete Physical
Time frame: day 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 pressure
Time frame: day 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)
Time frame: 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 Version
Time frame: day 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 Inventory
Time frame: day 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 Rate
Time frame: day 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 Rate
Time frame: day 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- between the ages of 8 and 17 years, inclusive
- abdominal pain of at least 8 weeks duration and fulfilling symptom-based criteria for functional dyspepsia(5);
- previous endoscopy with biopsies demonstrating \>20 eosinophils/high powered field on duodenal mucosal biopsies;
- previous treatment with acid-reduction therapy and montelukast with a level 3 (as defined below)or lesser response;
- evidence of written parental permission (consent) and subject assent;
- Negative pregnancy screening for females of child bearing potential.
Exclusion criteria
- previous treatment with ketotifen;
- treatment with oral corticosteroids or oral cromolyn sodium in the 6 months prior to enrollment;
- any prior history of diabetes mellitus, cancer, chronic cardiac disease, respiratory disease, or renal disease requiring routine medical care;
- Pregnant/planning to become pregnant;
- Post-menarche females unwilling to use highly-efficacious contraception to prevent pregnancy;
- Epilepsy or history of seizures;
- Liver disease or elevation of liver enzymes;
- Use of oral hypoglycemic medications, antipsychotics, benzodiazepines, tricyclic antidepressants, barbiturates, or opioids;
- Allergy to ketotifen or other products in capsule
- Refusal of Urine pregnancy test in post-menarchal females.
Where
- Kansas City, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 9, 2026 · Source of record for eligibility and locations