Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Tablet Rifaximin: Tablet Rifaximin 400 mg placed in a capsule three times a day for 28 days
Control Intervention1: Placebo: Placebo tablet placed in an identical looking capsule three t
Sponsors
Post Graduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2. Reduction in microscopic duodenal inflammationTimepoint: At 4 weeks At 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of improvement in quality of life at the end of treatment as assessed by the response to The ND Nepean Dyspepsia Index (NDI)(2 point reduction) 2. Reduction in duodenal bacterial count at 4 weeks 3. Overall treatment effect assessed on a 7 point Likert scale. 4. Sustenance of symptom relief at 8 weeksTimepoint: At 4 weeks At 8 weeks | — |
Countries
India
Contacts
Public ContactDeepak James
Post Graduate Institute of Medical Education and Research
Outcome results
None listed