MedDataX Logo

Rifaximin for Functional Dyspepsia

NCT ID: NCT01643083

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of this study is to test the effects of rifaximin, a minimally absorbed antibiotics, on symptoms of patients with functional dyspepsia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Functional Dyspepsia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rifaximin

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

Rifaximin 400mg tid for 2 wk

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for 2 week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rifaximin

Rifaximin 400mg tid for 2 wk

Intervention Type DRUG

Placebo

Placebo for 2 week

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Normix

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

LEUNG Wai Keung

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wai Keung Leung, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Queen Mary Hospital

Hong Kong, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28112426 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HKU_RD1

Identifier Type: -

Identifier Source: org_study_id