Skip to main content
OpenTrials
Completed

NCT Number: NCT01643083

Rifaximin for Functional Dyspepsia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Functional Dyspepsia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Queen Mary Hospital

Hong Kong, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifaximin

Drug

Rifaximin 400mg tid for 2 wk

Other names: Normix

Placebo

Drug

Placebo for 2 week

Primary outcomes

  1. Adequate relief of dyspeptic symptoms at end of treatment

    Time frame: end of treatment (week 2)

    global symptom improvement

Secondary outcomes

  1. Individual dyspeptic symptom scores

    Time frame: week 2, 4 and 8

    Hong Kong Dyspeptic Index

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2012
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.