Ketotifen treatment for children with functional dyspepsia and duodenal eosinophilia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of ketotifen, a mast cell stabilizer, in treating children aged 8 to 17 who suffer from functional dyspepsia associated with duodenal eosinophilia. The study is designed as a double-blind, placebo-controlled, cross-over trial, where participants will receive either ketotifen or a placebo in two phases. The primary goal is to assess the symptomatic response to ketotifen compared to placebo in children who have not adequately responded to standard acid-reduction therapy. Participants will undergo multiple clinic visits and phone interviews throughout the study duration to monitor their symptoms and overall health.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Children's Mercy Hospital
  Kansas City, Missouri, United States Recruiting

Study contacts

• Principal investigator: Craig A Friesen, MD — Children's Mercy Hospital Kansas City
• Study coordinator: Craig A Friesen, M.D.
• Email: cfriesen@cmh.edu
• Phone: 816-234-3066

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.