Comparison of the effect of the drug rifaximin with placebo in reducing the symptoms in patients with functional dyspepsia

Phase 3

• Conditions: Health Condition 1: K30- Functional dyspepsia

• Registration Number: CTRI/2019/10/021553
• Lead Sponsor: Post Graduate Institute of Medical Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Non-ulcer dyspepsia patients who fulfill epigastric pain syndrome or post-prandial distress syndrome criteria according to the Rome IV Criteria

2. Active dyspeptic symptoms

3. Normal upper endoscopy

Exclusion Criteria

1. Inability to provide written informed consent

2. No active dyspeptic symptoms

3. Allergic to rifaximin

4. Recent antibiotics use in the past 4 weeks

5. Recent PPI or H2RA in past 4 weeks

6. On anticoagulants, anticonvulsant or oral contraceptives

7. On NSAIDs, aspirin or Clopidogrel, complementary or alternative medicines

8. Pregnancy or breast feeding

9. Previous gastric surgery

10. Dysthyroidism

11. Abnormal liver or kidney function tests

12. Gall stone disease

13. HIV infection

14. Celiac disease

15. Rapid urease test/ antral biopsy for H. pylori positive

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Adequate relief of global dyspeptic symptoms at the end of treatment as assessed by a 5 point reduction in The Leeds Dyspepsia Questionnaire (LDQ) response <br/ ><br>2. Reduction in microscopic duodenal inflammationTimepoint: At 4 weeks <br/ ><br>At 8 weeks

Secondary Outcome Measures

Name	Time	Method
1.Assessment of improvement <br/ ><br>in quality of life at the end of treatment as assessed by the response to The ND Nepean Dyspepsia Index (NDI)(2 point reduction) <br/ ><br>2. Reduction in duodenal bacterial count at 4 weeks <br/ ><br>3. Overall treatment effect assessed on a 7 point Likert scale. <br/ ><br>4. Sustenance of symptom relief at 8 weeksTimepoint: At 4 weeks <br/ ><br>At 8 weeks