Effectiveness of Budesonide in patients with functional dyspepsia.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2015
INTERVENTION: 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. CONDITION: Functional Dyspepsia PRIMARY OUTCOME: Histological eosinophil quantitation and immunopathological evaluation Symptom reduction during the objective nutrient challenge test (participants will be asked to drink 200 ml of a liquid meal consisting of 3.8 g protein, 13.8 g carbohydrate, 3.4 g fat/100 ml every five minutes and report symptoms after a total of 600 ml). The questionnaire will ask about fullness, nausea, bloating and pain using a 100mm VAS scale from unnoticeable to unbearable. ; ; SECONDARY OUTCOME: Quality of life: Nepean Dyspepsia Index ; Th2 T cell responses in the duodenum (qPCR and explant culture). Diary ‐ abdominal symptom intensity: Mechanical Visual Analogue Scale (M‐VAS) Psychological distress (anxiety and depression): validated Hospital Anxiety and Depression Scale INCLUSION CRITERIA: Functional Dyspepsia patients with duodenal eosinophilia
Epistemonikos ID: 34bf2e58e120d793fb9ca8b729915737c4839fc8
First added on: Aug 23, 2024