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Rifaximin for Functional Dyspepsia

Primary Purpose

Functional Dyspepsia

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Rifaximin
Placebo
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring Post-prandial distress syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rifaximin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Adequate relief of dyspeptic symptoms at end of treatment
global symptom improvement

Secondary Outcome Measures

Individual dyspeptic symptom scores
Hong Kong Dyspeptic Index

Full Information

First Posted
July 15, 2012
Last Updated
November 30, 2015
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01643083
Brief Title
Rifaximin for Functional Dyspepsia
Official Title
Use of Rifaximin in Patients With Functional Dyspepsia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
Post-prandial distress syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Normix
Intervention Description
Rifaximin 400mg tid for 2 wk
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 2 week
Primary Outcome Measure Information:
Title
Adequate relief of dyspeptic symptoms at end of treatment
Description
global symptom improvement
Time Frame
end of treatment (week 2)
Secondary Outcome Measure Information:
Title
Individual dyspeptic symptom scores
Description
Hong Kong Dyspeptic Index
Time Frame
week 2, 4 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Keung Leung, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28112426
Citation
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.
Results Reference
derived

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Rifaximin for Functional Dyspepsia

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