The effect of antibiotic-resistant lactic acid bacteria on adverse events of H. pylori eradication therapy: A randamized control trial (Transitioned to jRCT)
Not Applicable
- Conditions
- Helicobacter pylori infection
- Registration Number
- JPRN-UMIN000030015
- Lead Sponsor
- Kobe University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients who have already taken H. pylori eradication therapy before. (2) Patients who had taken any antibiotics or PPI within 4 weeks before the start day of the study. (3) Patients under 20 years. (4) Patients who had taken gastric cancer sugery before (except endoscopic surgery). (5) Patients with severe renal impairment, serious heart disease, or severe liver disease. (6) Patients with allergy to the use drugs. (7) In the cases the test doctor has determined the patient does not fit the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The occurrence of diarrea during H. pylori eradication therapy (day 0 to day 6) in biofermin R administration group and placebo group.
- Secondary Outcome Measures
Name Time Method 1.Gut microflora change (alpha and beta divesity change) at day7, day 14 and pont of judgement after eradication therapy 2.Occurrence of side effect other than diarrhea 3.FSSG scal score before and after therapy 4.Serum diamine oxydase activity before and after therapy 5.Occurence of diarrhea after eradication therapy (between day 7 to day 13)