Evaluation of the effect of aspirin and a probiotic on functional dyspepsia

Phase 4

• Conditions: Functional Dyspepsia; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616001224415
• Lead Sponsor: niversity of Queensland,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Dyspepsia patients: We will study 90 consecutive patients with the diagnosis of FD according to Rome III criteria after a comprehensive negative diagnostic work-up.In order to avoid variability due to the menstrual cycle, all pre-menopausal females will be tested in the first phase of the menstrual cycle. All subjects will be H. pylori negative.
b) Controls: we will recruit 90 age and gender matched controls without GI symptoms undergoing endoscopy for assessment of iron deficiency with a normal upper endoscopy.
In order to avoid variability due to the menstrual cycle, all pre-menopausal females will be tested in the first phase of the menstrual cycle. All subjects will be H. pylori negative.

Exclusion Criteria

H. pylori positive

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pper GI function via Gastric emptying test- the termination half life will be used as outcome measure.<br>[Day 09 post commencement of treatment drug, <br>];Upper GI function-The peak and cumulative symptom responses will be determined and the cumulative scores for each symptom individually and for all symptoms combined will be used as the primary outcome variables - Gastric Emptying Test[Day 09 post commencement of treatment drug.];Activation of the immune function : Percentage of CD3+/CD4+/-CD8-/+ T cells from biopsy samples and percentage of memory/ gut homing T lymphocytes among CD4+ T cells in controls and patients with FD and assessment of the gastric and duodenal mucosa.<br><br>In Percentage of CD3+/CD4+/-CD8-/+ T cells and percentage of memory/ gut homing T lymphocytes among CD4+ T cells in controls and patients with FD. <br>[Tissue samples during endoscopic procedure and blood samples collected on 6th days post commencement of treatment. ]