A randomised controlled trial of antibiotic therapy in functional dyspepsia with and without non constipation irritable bowel syndrome

Not Applicable

Recruiting

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

• Registration Number: ACTRN12619001263189
• Lead Sponsor: Princess ALexandra Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-12
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients with a diagnosis of functional dyspepsia (Rome IV criteria) with a negative diagnostic work-up for organic disease and with and without non- constipation irritable bowel syndrome. Patients with H. pylori without visible other structural lesions will be included for assessment.

Exclusion Criteria

1) Unsuitable for therapy due to any medical conditions, drug allergies or inability to attend follow-up appointments; 2) Undergoing psychiatric treatment (e.g. full doses of antipsychotic, anxiolytic or antidepressant medication); 3) Insufficient language or literacy skills; 4) Antibiotic use in the previous 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom Score (GIS)[ Pre treatment and at 6 weeks from the start of treatment];Nepean Dyspepsia Index (NDI)[ Pre treatment and 6 weeks after the start of treatment];Symptom response to a nutrient challenge test<br><br>The nutrient challenge test is a standardised test of sensory function.<br><br>The test has been published<br>Haag S, Senf W, Tagay S, Heuft G, Gerken G, Talley NJ, Holtmann G. Is there any association between disturbed gastrointestinal visceromotor and sensory function and impaired quality of life in functional dyspepsia?. Neurogastroenterology & Motility. 2010 Mar;22(3):262-e79.[ Pre treatment and 6 weeks after the start of treatment]

Secondary Outcome Measures

Name	Time	Method
Density of bacterial colonisation of mucosal biopsies obtained from the 2nd part of the duodenum using the Brisbane Asceptic Biopsy device[ Pre treatment and 6 weeks after the start of treatment];Anxiety and depression from the Hospital Anxiety and Depression scale[ Pre treatment and 6 weeks after the start of treatment];Blood samples for immune markers as an exploratory outcome[ Pre treatment and 6 weeks after the start of treatment];Stool samples for immune markers as an exploratory outcome[ Pre treatment and 6 weeks after the start of treatment];Blood sample for microbiome markers as an exploratory outcome[ Pre treatment and 6 weeks after the start of treatment];Stool sample for microbiome markers as an exploratory outcome[ Pre treatment and 6 weeks after the start of treatment]