Rifaximin for Functional Dyspepsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01643083
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):
LEUNG Wai Keung, The University of Hong Kong

July 15, 2012
July 17, 2012
December 2, 2015
January 2013
May 2015   (Final data collection date for primary outcome measure)
Adequate relief of dyspeptic symptoms at end of treatment [ Time Frame: end of treatment (week 2) ]
global symptom improvement
Same as current
Complete list of historical versions of study NCT01643083 on Archive Site
Individual dyspeptic symptom scores [ Time Frame: week 2, 4 and 8 ]
Hong Kong Dyspeptic Index
Same as current
Not Provided
Not Provided
Rifaximin for Functional Dyspepsia
Use of Rifaximin in Patients With Functional Dyspepsia: A Randomized Controlled Trial
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.
The aim of this study is to test the effects of rifaximin, a minimally absorbed antibiotics, on symptoms of patients with functional dyspepsia.
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Functional Dyspepsia
  • Drug: Rifaximin
    Rifaximin 400mg tid for 2 wk
    Other Name: Normix
  • Drug: Placebo
    Placebo for 2 week
  • Active Comparator: Rifaximin
    Intervention: Drug: Rifaximin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Tan VP, Liu KS, Lam FY, Hung IF, Yuen MF, Leung WK. Randomised clinical trial: rifaximin versus placebo for the treatment of functional dyspepsia. Aliment Pharmacol Ther. 2017 Mar;45(6):767-776. doi: 10.1111/apt.13945. Epub 2017 Jan 23.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2015
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
LEUNG Wai Keung, The University of Hong Kong
The University of Hong Kong
Not Provided
Principal Investigator: Wai Keung Leung, MD The University of Hong Kong
The University of Hong Kong
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP