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Rifaximin for Functional Dyspepsia

This study is currently recruiting participants.
Verified June 2013 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
LEUNG Wai Keung, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01643083
First received: July 15, 2012
Last updated: June 5, 2013
Last verified: June 2013
History of Changes
  Purpose

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:

MedlinePlus related topics: Indigestion
Drug Information available for: Rifaximin
U.S. FDA Resources

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.

  Eligibility

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

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

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

Locations
China
Queen Mary Hospital Recruiting
Hong Kong, China
Contact: Wai Keung Leung, MD     85222553750        
Sponsors and Collaborators
The University of Hong Kong
Investigators
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: June 5, 2013
Health Authority: Hong Kong: Ethics Committee

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

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Stomach Diseases
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 17, 2013