None listed
Conditions
Brief summary
Functional dyspepsia affects a considerable proportion of Australians and results in significant personal and economic cost. There is as yet no cure for this condition and current treatments are generally not effective for the majority of people with functional dyspepsia. New research into the causes of functional dyspepsia have found that the numbers of a type of immune cell, the eosinophil, are increased in the top of the small bowel in patients with dyspepsia. A treatment called Budesonide has been shown to lower the amount of the eosinophils in the top of the small bowel. Budesonide is already an effective treatment in the management of other diseases including coeliac disease, collagenous sprue, oesophagitis and bronchitis. It is suspected that Budesonide will also be a promising treatment for functional dyspepsia but this needs to be properly tested. In this study we aim to test the effectiveness of Budesonide in people with functional dyspepsia in a randomised placebo controlled, double blind study.
Interventions
Budesonide
a) 9mg (1 effervescent tablet contains 3 mg budesonide/ taken 3 times daily)
b). Duration - 8 weeks
c) Dissolve EACH tablet in 50 mL of water and wait for tablet to finish effervescing. Then mix in with apple sauce and take 1 hour before meals.
d). Tablet return is the strategy used to monitor adherence.
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Functional Dyspepsia patients with duodenal eosinophilia
Exclusion criteria
Patients with type I diabetes, immunosuppression, active infection, TB, peptic ulcer, liver or renal disease, or osteoporosis.
Outcome results
None listed