CompletedPhase 2ACTRN12615000150549

Effectiveness of Budesonide in patients with functional dyspepsia.

A randomised placebo controlled, double blind study to evaluate the effectiveness of Budesonide in reducing symptoms in patients with functional dyspepsia


Sponsor

University of Newcastle

Enrollment

70 participants

Start Date

Dec 8, 2015

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Inclusion Criteria1

  • Functional Dyspepsia patients with duodenal eosinophilia

Exclusion Criteria1

  • Patients with type I diabetes, immunosuppression, active infection, TB, peptic ulcer, liver or renal disease, or osteoporosis.

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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.

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.


Locations(2)

John Hunter Hospital Royal Newcastle Centre - New Lambton

NSW,QLD, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD, Australia

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