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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

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.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Rifaximin Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Rifaximin in Patients With Functional Dyspepsia: A Randomized Controlled Trial
Study Start Date : January 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
Drug Information available for: Rifaximin

Arm Intervention/treatment
Active Comparator: Rifaximin Drug: Rifaximin
Rifaximin 400mg tid for 2 wk
Other Name: Normix

Placebo Comparator: Placebo Drug: Placebo
Placebo for 2 week

Primary Outcome Measures :
  1. Adequate relief of dyspeptic symptoms at end of treatment [ Time Frame: end of treatment (week 2) ]
    global symptom improvement

Secondary Outcome Measures :
  1. Individual dyspeptic symptom scores [ Time Frame: week 2, 4 and 8 ]
    Hong Kong Dyspeptic Index

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01643083

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Queen Mary Hospital
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
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Principal Investigator: Wai Keung Leung, MD The University of Hong Kong
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: LEUNG Wai Keung, Clinical Professor, The University of Hong Kong Identifier: NCT01643083    
Other Study ID Numbers: HKU_RD1
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by LEUNG Wai Keung, The University of Hong Kong:
Post-prandial distress syndrome
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents