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

A randomised controlled trial of antibiotic therapy on gastrointestinal and psychological symptoms and tissue bacterial density in functional dyspepsia with and without non constipation irritable bowel syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001263189

Enrollment

100

Registered

2019-09-12

Start date

2020-11-26

Completion date

2025-05-09

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Functional dyspepsia affects 1 in 6 Australians with currently no cure for this condition. This study aims to test the effects of antibiotic therapy on gastrointestinal symptoms, meal related quality of life (QoL), anxiety and depression and the symptom response to a standardised nutrient challenge (active therapy is superior to placebo) in up to 100 patients with functional dyspepsia with and without non constipation irritable bowel syndrome (IBS) attending the Department of Gastroenterology at the Princess Alexandra Hospital. By defining the effects of interventions targeting the gastrointestinal microbiota with regard to symptoms and gut function, we will pave the path for a paradigm shift regarding both treatment and overall understanding of the pathophysiology of functional dyspepsia. This will change how patients with functional dyspepsia are treated, enabling for the first time, targeting of the underlying causes of functional dyspepsia, which may ultimately cure this condition.

Interventions

Rifaximin (550g) 1 capsule twice a day for 14 days. Adherence will be monitored by drug tablet return

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

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

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.

Outcome results