Rifaximin for Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

Use of Rifaximin in Patients With Functional Dyspepsia: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643083
• Other study ID #: HKU_RD1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 15, 2012
• Last updated: November 30, 2015
• Start date: January 2013
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Drug:
• Rifaximin
Rifaximin 400mg tid for 2 wk
• Placebo
Placebo for 2 week

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate relief of dyspeptic symptoms at end of treatment	global symptom improvement	end of treatment (week 2)	No
Secondary	Individual dyspeptic symptom scores	Hong Kong Dyspeptic Index	week 2, 4 and 8	No