Rifaximin for Functional Dyspepsia
Use of Rifaximin in Patients With Functional Dyspepsia: A Randomized Controlled Trial
1 other identifier
interventional
95
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedDecember 2, 2015
November 1, 2015
2.3 years
July 15, 2012
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adequate relief of dyspeptic symptoms at end of treatment
global symptom improvement
end of treatment (week 2)
Secondary Outcomes (1)
Individual dyspeptic symptom scores
week 2, 4 and 8
Study Arms (2)
Rifaximin
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Mary Hospital
Hong Kong, China
Related Publications (1)
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.
PMID: 28112426DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wai Keung Leung, MD
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
July 15, 2012
First Posted
July 17, 2012
Study Start
January 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
December 2, 2015
Record last verified: 2015-11