Functional Dyspepsia | Rifaximin for Functional Dyspepsia
Functional Dyspepsia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:RifaximinRifaximin 400mg tid for 2 wk
Drug:PlaceboPlacebo for 2 week
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: January 2013
Completed Date: May 2015
Phase: Phase 2/Phase 3
Primary Outcome: Adequate relief of dyspeptic symptoms at end of treatment
Secondary Outcome: Individual dyspeptic symptom scores
Study sponsors, principal investigator, and references
Principal Investigator: Wai Keung Leung, MD
Lead Sponsor: The University of Hong Kong