Rifaximin for Functional Dyspepsia

Use of Rifaximin in Patients With Functional Dyspepsia: A Randomized Controlled Trial

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01643083

Enrollment

Registered

2012-07-17

Start date

2013-01-31

Completion date

2015-05-31

Last updated

2015-12-02

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

Conditions

Functional Dyspepsia

Keywords

Post-prandial distress syndrome

Brief summary

Functional dyspepsia is a very common medical condition, which occurs in up to 30% of people in the community. However, results of current pharmacological treatment on functional dyspepsia are unsatisfactory. Rifaximin is a minimally absorbed antibiotic that has been used in treatment of non-constipated irritable bowel syndrome (IBS). In particular, bloating and abdominal pain was improved by rifaximin treatment in this group of IBS patients. Whilst there is considerable overlap in symptoms of functional dyspepsia and IBS, the investigators test whether rifaximin is also effective in curing post-prandial distress symptoms related to dyspepsia.

Detailed description

The aim of this study is to test the effects of rifaximin, a minimally absorbed antibiotics, on symptoms of patients with functional dyspepsia.

Interventions

DRUGRifaximin

Rifaximin 400mg tid for 2 wk

DRUGPlacebo

Placebo for 2 week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Non-ulcer dyspeptic patients who fulfill post-prandial distress syndrome according to the Rome III Criteria * Active dyspeptic symptom * Normal upper endoscopy * Urea Breath Test -ve or Rapid urease test -ve * Not typical gastroesophageal reflux or biliary colic symptoms, but presence of infrequent acid reflux is allowed

Exclusion criteria

* No active dyspeptic symptom * Allergic to rifaximin * Recent antibiotics use in the past 8 wk * Recent PPI or H2RA in past 4 wk * On anti-coagulants, anti-convulsant or oral contraceptives * On NSAIDs, aspirin or Clopidogrel * Pregnancy or breast feeding * Previous gastric surgery

Design outcomes

Primary

Measure	Time frame	Description
Adequate relief of dyspeptic symptoms at end of treatment	end of treatment (week 2)	global symptom improvement

Secondary

Measure	Time frame	Description
Individual dyspeptic symptom scores	week 2, 4 and 8	Hong Kong Dyspeptic Index

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026