Rifaximin for Functional Dyspepsia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by The University of Hong Kong
Information provided by (Responsible Party):
LEUNG Wai Keung, The University of Hong Kong
ClinicalTrials.gov Identifier:
First received: July 15, 2012
Last updated: December 1, 2014
Last verified: December 2014

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.

Condition Intervention Phase
Functional Dyspepsia
Drug: Rifaximin
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Rifaximin in Patients With Functional Dyspepsia: A Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Adequate relief of dyspeptic symptoms at end of treatment [ Time Frame: end of treatment (week 2) ] [ Designated as safety issue: No ]
    global symptom improvement

Secondary Outcome Measures:
  • Individual dyspeptic symptom scores [ Time Frame: week 2, 4 and 8 ] [ Designated as safety issue: No ]
    Hong Kong Dyspeptic Index

Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rifaximin Drug: Rifaximin
Rifaximin 400mg tid for 2 wk
Other Name: Normix
Placebo Comparator: Placebo Drug: Placebo
Placebo for 2 week

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643083

Contact: Wai Keung Leung, MD 85222553750 waikleung@hku.hk

Queen Mary Hospital Recruiting
Hong Kong, China
Contact: Wai Keung Leung, MD    85222553750      
Sponsors and Collaborators
The University of Hong Kong
Principal Investigator: Wai Keung Leung, MD The University of Hong Kong
  More Information

No publications provided

Responsible Party: LEUNG Wai Keung, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01643083     History of Changes
Other Study ID Numbers: HKU_RD1
Study First Received: July 15, 2012
Last Updated: December 1, 2014
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Post-prandial distress syndrome

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Anti-Infective Agents
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 26, 2015